nicardipine has been researched along with Stroke in 28 studies
Nicardipine: A potent calcium channel blockader with marked vasodilator action. It has antihypertensive properties and is effective in the treatment of angina and coronary spasms without showing cardiodepressant effects. It has also been used in the treatment of asthma and enhances the action of specific antineoplastic agents.
nicardipine : A racemate comprising equimolar amounts of (R)- and (S)-nicardipine. It is a calcium channel blocker which is used to treat hypertension.
2-[benzyl(methyl)amino]ethyl methyl 2,6-dimethyl-4-(3-nitrophenyl)-1,4-dihydropyridine-3,5-dicarboxylate : A dihydropyridine that is 1,4-dihydropyridine substituted by a methyl, {2-[benzyl(methyl)amino]ethoxy}carbonyl, 3-nitrophenyl, methoxycarbonyl and methyl groups at positions 2, 3, 4, 5 and 6, respectively.
Stroke: A group of pathological conditions characterized by sudden, non-convulsive loss of neurological function due to BRAIN ISCHEMIA or INTRACRANIAL HEMORRHAGES. Stroke is classified by the type of tissue NECROSIS, such as the anatomic location, vasculature involved, etiology, age of the affected individual, and hemorrhagic vs. non-hemorrhagic nature. (From Adams et al., Principles of Neurology, 6th ed, pp777-810)
Excerpt | Relevance | Reference |
---|---|---|
"Rapid lowering of systolic blood pressure by continuous administration of intravenous nicardipine during the initial 24 h in hyperacute intracerebral hemorrhage was associated with lower risks of hematoma expansion and 90-day death or disability without increasing serious adverse events." | 9.22 | Intensive blood pressure lowering with nicardipine and outcomes after intracerebral hemorrhage: An individual participant data systematic review. ( Fukuda-Doi, M; Hsu, CY; Ihara, M; Inoue, M; Itabashi, R; Koga, M; Martin, RH; Minematsu, K; Okada, Y; Palesch, YY; Qureshi, AI; Sakai, N; Steiner, T; Suarez, JI; Toyoda, K; Wang, Y; Yamagami, H; Yamamoto, H; Yoon, BW; Yoshimura, S, 2022) |
"In acutely hypertensive stroke patients, superior therapeutic response was achieved with nicardipine versus labetalol." | 9.17 | A prospective evaluation of labetalol versus nicardipine for blood pressure management in patients with acute stroke. ( Coplin, W; Levy, PD; Liu-DeRyke, X; Parker, D; Rhoney, DH, 2013) |
"In patients with hemorrhagic stroke, nicardipine appeared to have similar efficacy as clevidipine in SBP reduction, with a more likely reduction of rebound hypertension and drug cost." | 8.12 | Comparison of Clevidipine and Nicardipine for Acute Blood Pressure Reduction in Hemorrhagic Stroke. ( Breslin, J; Hanify, J; Heierman, T; Larizadeh, K; Phipps, W; Saldana, S; Sanchez, M, 2022) |
"These results indicate that CIV-labetalol and CIV-nicardipine are comparable in safety and efficacy in controlling BP for patients with acute stroke." | 8.02 | Blood Pressure Control in Acute Stroke: Labetalol or Nicardipine? ( El-Ghoroury, H; Hecht, JP; Sudekum, DM, 2021) |
" Nicardipine and labetalol are commonly administered for the treatment of acute hypertension following stroke." | 7.91 | Nicardipine Associated Risk of Short-Term Mortality in Critically Ill Patients with Ischemic Stroke. ( Desai, A; Hanni, C; Mohamed, W; Parker, D; Saber, H; Sadeghi, M; Singh, A, 2019) |
"Labetalol and nicardipine are antihypertensives commonly used in the management of elevated blood pressure (BP) following an acute stroke, but there is limited evidence to suggest which agent as a continuous infusion should be used preferentially in this setting." | 7.88 | Continuous-Infusion Labetalol vs Nicardipine for Hypertension Management in Stroke Patients. ( Hecht, JP; Richards, PG, 2018) |
"Nicardipine is frequently used in the treatment of hypertension for patients with acute stroke; however, its dosing is complicated by a high risk of phlebitis." | 7.88 | Reduction of Nicardipine-Related Phlebitis in Patients with Acute Stroke by Diluting Its Concentration. ( Kawada, K; Miyamoto, N; Ohta, T; Tanaka, K, 2018) |
"Nicardipine is a dihydropyridine calcium-channel blocker that is frequently used in the acute treatment of hypertension in the emergency department (ED)." | 7.83 | Bradycardia caused by intravenous nicardipine in an elderly patient with acute ischemic infarct. ( Abboud, ME; Frasure, SE, 2016) |
"Intravenous nicardipine is generally used to treat hypertension in acute stroke patients but is associated with frequent phlebitis." | 7.83 | Risk Factors of Nicardipine-Related Phlebitis in Acute Stroke Patients. ( Kadoguchi, N; Kawada, K; Morimoto, M; Ohta, T; Tanaka, K; Yamamoto, S, 2016) |
"This study aimed to compare the effects of labetalol, nicardipine, or hydralazine on time to target blood pressure before alteplase administration in patients with acute ischemic stroke." | 7.81 | Time to Blood Pressure Control Before Thrombolytic Therapy in Patients With Acute Ischemic Stroke: Comparison of Labetalol, Nicardipine, and Hydralazine. ( Cortes, J; Hall, AB; McKay, C, 2015) |
"American Heart Association/American Stroke Association guidelines for management of aneurysmal subarachnoid hemorrhage (aSAH) recommend blood pressure (BP) control, utilizing labetalol or nicardipine, but do not differentiate efficacy between the two agents." | 7.78 | Retrospective evaluation of nicardipine versus labetalol for blood pressure control in aneurysmal subarachnoid hemorrhage. ( Barletta, JF; DeShane, RS; Figueroa, BE; McAllen, KJ; Woloszyn, AV, 2012) |
"Evaluate the ease of use and tolerability of labetalol (L) and nicardipine (N) for hypertension management in patients with acute stroke." | 7.74 | A comparison of nicardipine and labetalol for acute hypertension management following stroke. ( Coplin, WM; Janisse, J; Liu-Deryke, X; Norris, G; Parker, D; Rhoney, DH, 2008) |
"Intra-arterial delivery of nicardipine in doses up to 5 mg is well tolerated among patients with acute ischemic stroke." | 7.74 | Preliminary experience with intra-arterial nicardipine in patients with acute ischemic stroke. ( Georgiadis, A; Qureshi, AI; Rodriguez, G; Shah, QA; Suri, MF, 2007) |
"Rapid lowering of systolic blood pressure by continuous administration of intravenous nicardipine during the initial 24 h in hyperacute intracerebral hemorrhage was associated with lower risks of hematoma expansion and 90-day death or disability without increasing serious adverse events." | 5.22 | Intensive blood pressure lowering with nicardipine and outcomes after intracerebral hemorrhage: An individual participant data systematic review. ( Fukuda-Doi, M; Hsu, CY; Ihara, M; Inoue, M; Itabashi, R; Koga, M; Martin, RH; Minematsu, K; Okada, Y; Palesch, YY; Qureshi, AI; Sakai, N; Steiner, T; Suarez, JI; Toyoda, K; Wang, Y; Yamagami, H; Yamamoto, H; Yoon, BW; Yoshimura, S, 2022) |
"In acutely hypertensive stroke patients, superior therapeutic response was achieved with nicardipine versus labetalol." | 5.17 | A prospective evaluation of labetalol versus nicardipine for blood pressure management in patients with acute stroke. ( Coplin, W; Levy, PD; Liu-DeRyke, X; Parker, D; Rhoney, DH, 2013) |
"In patients with hemorrhagic stroke, nicardipine appeared to have similar efficacy as clevidipine in SBP reduction, with a more likely reduction of rebound hypertension and drug cost." | 4.12 | Comparison of Clevidipine and Nicardipine for Acute Blood Pressure Reduction in Hemorrhagic Stroke. ( Breslin, J; Hanify, J; Heierman, T; Larizadeh, K; Phipps, W; Saldana, S; Sanchez, M, 2022) |
"0) had significantly higher odds of death within 90 days after adjustment for age, race and ethnicity, National Institutes of Health Stroke Scale score strata, hematoma volume, presence or absence of intraventricular hemorrhage, cigarette smoking, previous stroke, and maximum hourly dose of nicardipine." | 4.12 | Early Hyperchloremia is Independently Associated with Death or Disability in Patients with Intracerebral Hemorrhage. ( Hanley, DF; Hsu, CY; Huang, W; Malhotra, K; Martin, RH; Qureshi, AI; Steiner, T; Suarez, JI; Toyoda, K; Yamamoto, H, 2022) |
"These results indicate that CIV-labetalol and CIV-nicardipine are comparable in safety and efficacy in controlling BP for patients with acute stroke." | 4.02 | Blood Pressure Control in Acute Stroke: Labetalol or Nicardipine? ( El-Ghoroury, H; Hecht, JP; Sudekum, DM, 2021) |
" Nicardipine and labetalol are commonly administered for the treatment of acute hypertension following stroke." | 3.91 | Nicardipine Associated Risk of Short-Term Mortality in Critically Ill Patients with Ischemic Stroke. ( Desai, A; Hanni, C; Mohamed, W; Parker, D; Saber, H; Sadeghi, M; Singh, A, 2019) |
"OBJECTIVE Intravenous nicardipine is commonly used for blood pressure reduction in patients with acute stroke." | 3.88 | Paradoxical cerebrovascular hemodynamic changes with nicardipine. ( Lahiri, S; Lyden, PD; Mayer, SA; Nezhad, M; Rinsky, B; Rosengart, A; Schlick, KH, 2018) |
"The Stroke Acute Management with Urgent Risk-factor Assessment and Improvement (SAMURAI)-ICH Study was a multicenter, prospective, observational study investigating the safety and feasibility of early (within 3 h from onset) reduction of systolic BP (SBP) to < 160 mm Hg with intravenous nicardipine for acute hypertension in cases of spontaneous ICH." | 3.88 | Early Achievement of Blood Pressure Lowering and Hematoma Growth in Acute Intracerebral Hemorrhage: Stroke Acute Management with Urgent Risk-Factor Assessment and Improvement-Intracerebral Hemorrhage Study. ( Ando, D; Fujita, K; Hasegawa, Y; Ide, T; Itabashi, R; Kamimura, T; Kamiyama, K; Kario, K; Kimura, K; Koga, M; Kumamoto, M; Matsubara, S; Nagatsuka, K; Okada, Y; Okuda, S; Sato, S; Shiokawa, Y; Shiozawa, M; Todo, K; Toyoda, K; Yamagami, H; Yamaguchi, Y; Yoshimoto, T; Yoshimura, S, 2018) |
"Nicardipine is frequently used in the treatment of hypertension for patients with acute stroke; however, its dosing is complicated by a high risk of phlebitis." | 3.88 | Reduction of Nicardipine-Related Phlebitis in Patients with Acute Stroke by Diluting Its Concentration. ( Kawada, K; Miyamoto, N; Ohta, T; Tanaka, K, 2018) |
"Labetalol and nicardipine are antihypertensives commonly used in the management of elevated blood pressure (BP) following an acute stroke, but there is limited evidence to suggest which agent as a continuous infusion should be used preferentially in this setting." | 3.88 | Continuous-Infusion Labetalol vs Nicardipine for Hypertension Management in Stroke Patients. ( Hecht, JP; Richards, PG, 2018) |
"Intravenous nicardipine is generally used to treat hypertension in acute stroke patients but is associated with frequent phlebitis." | 3.83 | Risk Factors of Nicardipine-Related Phlebitis in Acute Stroke Patients. ( Kadoguchi, N; Kawada, K; Morimoto, M; Ohta, T; Tanaka, K; Yamamoto, S, 2016) |
"Nicardipine is a dihydropyridine calcium-channel blocker that is frequently used in the acute treatment of hypertension in the emergency department (ED)." | 3.83 | Bradycardia caused by intravenous nicardipine in an elderly patient with acute ischemic infarct. ( Abboud, ME; Frasure, SE, 2016) |
"This study aimed to compare the effects of labetalol, nicardipine, or hydralazine on time to target blood pressure before alteplase administration in patients with acute ischemic stroke." | 3.81 | Time to Blood Pressure Control Before Thrombolytic Therapy in Patients With Acute Ischemic Stroke: Comparison of Labetalol, Nicardipine, and Hydralazine. ( Cortes, J; Hall, AB; McKay, C, 2015) |
"American Heart Association/American Stroke Association guidelines for management of aneurysmal subarachnoid hemorrhage (aSAH) recommend blood pressure (BP) control, utilizing labetalol or nicardipine, but do not differentiate efficacy between the two agents." | 3.78 | Retrospective evaluation of nicardipine versus labetalol for blood pressure control in aneurysmal subarachnoid hemorrhage. ( Barletta, JF; DeShane, RS; Figueroa, BE; McAllen, KJ; Woloszyn, AV, 2012) |
"Intra-arterial delivery of nicardipine in doses up to 5 mg is well tolerated among patients with acute ischemic stroke." | 3.74 | Preliminary experience with intra-arterial nicardipine in patients with acute ischemic stroke. ( Georgiadis, A; Qureshi, AI; Rodriguez, G; Shah, QA; Suri, MF, 2007) |
"Evaluate the ease of use and tolerability of labetalol (L) and nicardipine (N) for hypertension management in patients with acute stroke." | 3.74 | A comparison of nicardipine and labetalol for acute hypertension management following stroke. ( Coplin, WM; Janisse, J; Liu-Deryke, X; Norris, G; Parker, D; Rhoney, DH, 2008) |
"Nicardipine is a dihydropyridine-type Ca(2+) channel blocker (CCB) with strong antihypertensive activity and with a peculiar cerebrovascular profile." | 2.45 | Nicardipine use in cerebrovascular disease: a review of controlled clinical studies. ( Amenta, F; Lanari, A; Mignini, F; Silvestrelli, G; Tomassoni, D; Traini, E, 2009) |
"Nicardipine has been studied or recommended for management of hypertension in many neurovascular settings (ischemic stroke, intracerebral hemorrhage, craniotomy, and spinal surgery), for vasospasm in aneurysmal subarachnoid hemorrhage, and in acute traumatic brain injury." | 2.45 | Use of injectable nicardipine for neurovascular indications. ( Reddy, P; Yeh, YC, 2009) |
"Nicardipine is a dihydropyridine-type calcium channel blocker (CCB) with a peculiar cerebrovascular profile developed approximately 30 years ago." | 2.44 | Nicardipine: a hypotensive dihydropyridine-type calcium antagonist with a peculiar cerebrovascular profile. ( Amenta, F; Mignini, F; Tomassoni, D; Traini, E; Veglio, F, 2008) |
"In the case of hypertensive encephalopathy, the lowering of blood pressure is therapeutic as well as diagnostic." | 2.43 | [Antihypertensive management in acute cerebral stroke]. ( Ziliene, V, 2005) |
"Hypertension that complicates preeclampsia in pregnancy is a disorder that requires special consideration in both prevention and pharmacologic treatment." | 2.43 | Pathophysiology and medical management of systemic hypertension in preeclampsia. ( Frishman, WH; Schlocker, SJ; Tejani, N; Veresh, M, 2006) |
Timeframe | Studies, this research(%) | All Research% |
---|---|---|
pre-1990 | 0 (0.00) | 18.7374 |
1990's | 0 (0.00) | 18.2507 |
2000's | 10 (35.71) | 29.6817 |
2010's | 12 (42.86) | 24.3611 |
2020's | 6 (21.43) | 2.80 |
Authors | Studies |
---|---|
Toyoda, K | 3 |
Yoshimura, S | 2 |
Fukuda-Doi, M | 1 |
Qureshi, AI | 3 |
Martin, RH | 2 |
Palesch, YY | 1 |
Ihara, M | 1 |
Suarez, JI | 2 |
Okada, Y | 2 |
Hsu, CY | 2 |
Itabashi, R | 2 |
Wang, Y | 1 |
Yamagami, H | 2 |
Steiner, T | 2 |
Sakai, N | 1 |
Yoon, BW | 1 |
Inoue, M | 1 |
Minematsu, K | 1 |
Yamamoto, H | 2 |
Koga, M | 2 |
Martini, BE | 1 |
Schalk, AL | 1 |
Saldana, S | 1 |
Breslin, J | 1 |
Hanify, J | 1 |
Heierman, T | 1 |
Larizadeh, K | 1 |
Sanchez, M | 1 |
Phipps, W | 1 |
Huang, W | 1 |
Hanley, DF | 1 |
Malhotra, K | 1 |
Carrera, JF | 1 |
Sorace, BJ | 1 |
Worrall, BB | 1 |
Southerland, AM | 1 |
Chiota-McCollum, NA | 1 |
El-Ghoroury, H | 1 |
Sudekum, DM | 1 |
Hecht, JP | 2 |
Lahiri, S | 1 |
Nezhad, M | 1 |
Schlick, KH | 1 |
Rinsky, B | 1 |
Rosengart, A | 1 |
Mayer, SA | 2 |
Lyden, PD | 1 |
Richards, PG | 1 |
Kawada, K | 2 |
Ohta, T | 2 |
Tanaka, K | 2 |
Miyamoto, N | 1 |
Mistry, EA | 1 |
Khatri, P | 1 |
Yamaguchi, Y | 1 |
Sato, S | 1 |
Todo, K | 1 |
Okuda, S | 1 |
Kimura, K | 1 |
Shiokawa, Y | 1 |
Kamiyama, K | 1 |
Hasegawa, Y | 1 |
Kario, K | 1 |
Fujita, K | 1 |
Kumamoto, M | 1 |
Kamimura, T | 1 |
Ando, D | 1 |
Ide, T | 1 |
Yoshimoto, T | 1 |
Shiozawa, M | 1 |
Matsubara, S | 1 |
Nagatsuka, K | 1 |
Sadeghi, M | 1 |
Saber, H | 1 |
Singh, A | 1 |
Hanni, C | 1 |
Parker, D | 3 |
Desai, A | 1 |
Mohamed, W | 1 |
Liu-DeRyke, X | 2 |
Levy, PD | 1 |
Coplin, W | 1 |
Rhoney, DH | 2 |
Abboud, ME | 1 |
Frasure, SE | 1 |
McKay, C | 1 |
Hall, AB | 1 |
Cortes, J | 1 |
Kadoguchi, N | 1 |
Yamamoto, S | 1 |
Morimoto, M | 1 |
Amenta, F | 2 |
Tomassoni, D | 2 |
Traini, E | 2 |
Mignini, F | 2 |
Veglio, F | 1 |
Lanari, A | 1 |
Silvestrelli, G | 1 |
Reddy, P | 1 |
Yeh, YC | 1 |
Fletcher, JJ | 1 |
Kramer, AH | 1 |
Bleck, TP | 1 |
Solenski, NJ | 1 |
Powers, WJ | 1 |
Videen, TO | 1 |
Diringer, MN | 1 |
Aiyagari, V | 1 |
Zazulia, AR | 1 |
Miller, M | 1 |
Kumar, AB | 1 |
Callison, CR | 1 |
Woloszyn, AV | 1 |
McAllen, KJ | 1 |
Figueroa, BE | 1 |
DeShane, RS | 1 |
Barletta, JF | 1 |
Ziliene, V | 1 |
Frishman, WH | 1 |
Veresh, M | 1 |
Schlocker, SJ | 1 |
Tejani, N | 1 |
Wong, GK | 1 |
Poon, WS | 1 |
Shah, QA | 1 |
Georgiadis, A | 1 |
Suri, MF | 1 |
Rodriguez, G | 1 |
Janisse, J | 1 |
Coplin, WM | 1 |
Norris, G | 1 |
Trial | Phase | Enrollment | Study Type | Start Date | Status | ||
---|---|---|---|---|---|---|---|
Antihypertensive Treatment of Acute Cerebral Hemorrhage (ATACH)-II: A Phase III Randomized Multicenter Clinical Trial of Blood Pressure Reduction for Hypertension in Acute Intracerebral Hemorrhage[NCT01176565] | Phase 3 | 1,000 participants (Actual) | Interventional | 2011-05-15 | Terminated (stopped due to Planned interim analysis: no significant outcome differences between groups) | ||
[information is prepared from clinicaltrials.gov, extracted Sep-2024] |
The complete count of all subjects who experienced any serious adverse events throughout their participation in the trial was included in this tabulation. Adverse events (AEs) and serious adverse events (SAEs) were assessed by the site investigators for all patients. Potential relatedness to the study treatment was a required reporting element for all adverse events but was not considered in this count. Terminology from the Medical Dictionary for Regulatory Activities (MedDRA) and severity criteria from the Common Terminology Criteria for Adverse Events (CTCAE v. 4.03) were used as a basis for reporting adverse events. Serious adverse events are defined as being fatal, life-threatening, resulting in hospitalization or prolonged hospitalization, resulting in disability or congenital anomaly, or requiring intervention to prevent permanent impairment or damage and were required to be reported promptly. An Independent Oversight Committee (IOC) reviewed and adjudicated adverse event data. (NCT01176565)
Timeframe: From randomization through the 90 day visit (90 ± 14 days per protocol window; up to ± 30 days data is used) or until known death, withdrawal, or loss to follow-up.
Intervention | Participants (Count of Participants) |
---|---|
Standard SBP Reduction Arm | 100 |
Intensive SBP Reduction Arm | 128 |
Hematoma expansion as determined by serial CT scans: Hematoma expansion was defined as an increase in the volume of intraparenchymal hemorrhage of 33% or greater as measured by a central imaging analyst who was was unaware of the treatment assignments, clinical findings, and time points of image acquisition. The area of the hematoma was delineated by image analysis software with the use of density thresholds on each slice, followed by manual correction. To ensure accuracy and consistency of the readings, images were coded randomly and independently of subject numbers and manual correction was also done without awareness of treatment assignments, clinical findings, or time points of image acquisition. This data point is defined as being present (hematoma expansion of 33% or more was calculated between the baseline scan hematoma volume and the 24 +/- 6 hours hematoma volume measures at data analysis), meaning that hematoma expansion as defined must have occurred or it was not counted. (NCT01176565)
Timeframe: From the baseline head CT to the 24 +/- 6 hours from randomization head CT
Intervention | Participants (Count of Participants) |
---|---|
Standard SBP Reduction Arm | 104 |
Intensive SBP Reduction Arm | 85 |
Hypotension (abnormally low blood pressure) was the most likely adverse event that could be associated with the study treatment, and is the primary basis (risk) on which neurological deterioration or other untoward effects of the study treatment could occur. It is therefore examined as a numerically-measured occurrence in addition to monitoring patients closely for neurological deterioration or other symptoms. Hypotension, when named as an adverse event, was defined as the syndrome of low blood pressure with SBP < 85 mmHg. Instances of hypotension were to be avoided through close monitoring, and administration of fluid bolus for SBP < 110 mmHg. If hypotension did occur, it was to be reversed as quickly as possible through discontinuation of intravenous nicardipine and intravenous fluid administration, which can be accomplished readily in a variety of settings where patients with intracerebral hemorrhage are routinely housed during early hospitalization. (NCT01176565)
Timeframe: From randomization through 72 hours from randomization
Intervention | Participants (Count of Participants) |
---|---|
Standard SBP Reduction Arm | 3 |
Intensive SBP Reduction Arm | 6 |
Neurologic deterioration was measured using two scales. The Glasgow Coma Scale (GCS) score measures of level of consciousness in eye, motor, and verbal components. At least one point is given in each category. The scale ranges from 3 to 15, with 3 indicating deep unconsciousness and 15 indicating consciousness is not impaired. The National Institutes of Health Stroke Scale (NIHSS) quantifies neurologic deficits in 11 categories. Level of consciousness, horizontal eye movement, visual fields, facial palsy, movement in each limb, sensation, language & speech, and extinction or inattention on one side of the body are tested. Scores range from 0 to 42, with 0 indicating normal function and higher scores indicating greater deficit severity. Neurological status was checked per ICU standards through 24 hours, recommended as hourly GCS and full assessment every 2 hours. NIHSS assessment at baseline and 24 +/- 3 hours was pre-specified. Assessments were added for suspected neurological change. (NCT01176565)
Timeframe: From randomization through the 24-hour treatment period
Intervention | Participants (Count of Participants) |
---|---|
Standard SBP Reduction Arm | 40 |
Intensive SBP Reduction Arm | 55 |
Adverse events (AEs) and serious adverse events (SAEs) were assessed by the site investigators for all patients, including for their potential relatedness to the study treatment. An Independent Oversight Committee (IOC) reviewed and adjudicated all adverse event data. The 72-hours-from-randomization time window was considered the most likely time frame during which treatment-related adverse events or serious adverse events would be observed. Terminology from the Medical Dictionary for Regulatory Activities (MedDRA) and severity criteria from the Common Terminology Criteria for Adverse Events (CTCAE v. 4.03) were used as a basis for reporting adverse events. Serious adverse events are defined as being fatal, life-threatening, resulting in hospitalization or prolonged hospitalization, resulting in disability or congenital anomaly, or requiring intervention to prevent permanent impairment or damage and were required to be reported promptly. (NCT01176565)
Timeframe: From randomization through 72 hours (3 days)
Intervention | Participants (Count of Participants) |
---|---|
Standard SBP Reduction Arm | 6 |
Intensive SBP Reduction Arm | 8 |
The primary outcome was death or disability, defined by modified Rankin scale (mRS) of 4-6 at 90 days following treatment. The modified Rankin Scale score ranges from 0, indicating no symptoms, to 6, indicating death. A score of 4 indicates moderately severe disability including the inability to walk or attend to one's own bodily needs. A score of 5 indicates severe disability; bedridden, incontinent, and requiring constant nursing care. To score a 3 or lower on the mRS, a person must at least be able to walk without the assistance of another person. We chose the mRS because of its high inter-observer reliability, superiority to other indices, and consistency with previous trials in patients with ICH. Reliability was further increased by use of a structured interview template and by requiring mRS assessors to pass a certification test. Persons conducting the 90-day mRS assessment were to be unaware of the treatment arm or clinical course of the patients they assessed. (NCT01176565)
Timeframe: 90 days (± 14 days per protocol window; up to ± 30 days data is used) from randomization
Intervention | Participants (Count of Participants) | |
---|---|---|
Death or disability at 90 days (mRS = 4 - 6) | Known death at or before 90 days | |
Intensive SBP Reduction Arm | 186 | 33 |
Standard SBP Reduction Arm | 181 | 34 |
Standardized scales developed by the EuroQol Research Foundation were used as a secondary outcome measure in addition to the mRS scale score. The EQ-5D is a simple, standardized non-disease-specific instrument for describing and valuating health-related quality of life. The EQ-5D-3L questionnaire consists of 5 questions in 5 different domains and allows for responses from 1 (the best outcome) to 3 (the worst outcome) in each of five categories (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression). Total scores range from 5 to 15, with lower scores indicating better quality of life and a higher score indicating a worse quality of life. A second component of EuroQol outcome measurements is a printed 20 cm visual analogue scale (EQ VAS) that appears somewhat like a thermometer, on which a score from 0 (worst imaginable health state or death) to 100 (best imaginable health state) is marked by the patient (or, when necessary, their proxy) with the scale in view. (NCT01176565)
Timeframe: 90 days (± 14 days per protocol window; up to ± 30 days data is used) from randomization
Intervention | units on a scale (Median) | |
---|---|---|
EQ-5D utility scale questionnaire | EQ VAS (visual analog scale) | |
Intensive SBP Reduction Arm | 0.7 | 62.5 |
Standard SBP Reduction Arm | 0.7 | 70 |
6 reviews available for nicardipine and Stroke
Article | Year |
---|---|
Intensive blood pressure lowering with nicardipine and outcomes after intracerebral hemorrhage: An individual participant data systematic review.
Topics: Aged; Antihypertensive Agents; Blood Pressure; Cerebral Hemorrhage; Female; Hematoma; Humans; Male; | 2022 |
Nicardipine: a hypotensive dihydropyridine-type calcium antagonist with a peculiar cerebrovascular profile.
Topics: Antihypertensive Agents; Blood Pressure; Calcium Channel Blockers; Cerebrovascular Disorders; Dement | 2008 |
Nicardipine use in cerebrovascular disease: a review of controlled clinical studies.
Topics: Antihypertensive Agents; Calcium Channel Blockers; Cerebrovascular Disorders; Cognition; Cognition D | 2009 |
Use of injectable nicardipine for neurovascular indications.
Topics: Antihypertensive Agents; Cerebral Hemorrhage; Humans; Hypertension; Injections; Meta-Analysis as Top | 2009 |
[Antihypertensive management in acute cerebral stroke].
Topics: Acute Disease; Adult; Antihypertensive Agents; Brain Injuries; Cerebrovascular Circulation; Emergenc | 2005 |
Pathophysiology and medical management of systemic hypertension in preeclampsia.
Topics: Adrenergic beta-Antagonists; Aspirin; Calcium; Calcium Channel Blockers; Cerebral Hemorrhage; Female | 2006 |
1 trial available for nicardipine and Stroke
Article | Year |
---|---|
A prospective evaluation of labetalol versus nicardipine for blood pressure management in patients with acute stroke.
Topics: Aged; Antihypertensive Agents; APACHE; Blood Pressure; Female; Hospital Mortality; Humans; Hypertens | 2013 |
21 other studies available for nicardipine and Stroke
Article | Year |
---|---|
Comparison of premade clevidipine and pharmacy-prepared nicardipine in time to goal systolic blood pressure in acute cerebrovascular accident.
Topics: Antihypertensive Agents; Blood Pressure; Goals; Humans; Hypertension; Nicardipine; Pharmacy; Pyridin | 2022 |
Comparison of Clevidipine and Nicardipine for Acute Blood Pressure Reduction in Hemorrhagic Stroke.
Topics: Acute Kidney Injury; Adult; Antihypertensive Agents; Blood Pressure; Bradycardia; Hematoma; Hemorrha | 2022 |
Early Hyperchloremia is Independently Associated with Death or Disability in Patients with Intracerebral Hemorrhage.
Topics: Antihypertensive Agents; Cerebral Hemorrhage; Chlorides; Humans; Nicardipine; Stroke | 2022 |
Delay to Tissue Plasminogen Activator in Hypertensive Stroke Patients: An Analysis of Delay Duration Across Agents.
Topics: Aged; Antihypertensive Agents; Blood Pressure; Drug Administration Schedule; Female; Fibrinolytic Ag | 2020 |
Blood Pressure Control in Acute Stroke: Labetalol or Nicardipine?
Topics: Adrenergic alpha-1 Receptor Antagonists; Aged; Aged, 80 and over; Antihypertensive Agents; Blood Pre | 2021 |
Paradoxical cerebrovascular hemodynamic changes with nicardipine.
Topics: Administration, Intravenous; Adult; Aged; Aneurysm, Ruptured; Blood Flow Velocity; Calcium Channel B | 2018 |
Continuous-Infusion Labetalol vs Nicardipine for Hypertension Management in Stroke Patients.
Topics: Adrenergic beta-Antagonists; Aged; Aged, 80 and over; Antihypertensive Agents; Blood Pressure; Calci | 2018 |
Reduction of Nicardipine-Related Phlebitis in Patients with Acute Stroke by Diluting Its Concentration.
Topics: Administration, Intravenous; Aged; Aged, 80 and over; Antihypertensive Agents; Female; Humans; Hyper | 2018 |
Blood Pressure Management after Mechanical Thrombectomy for Acute Ischemic Stroke: A Survey of the StrokeNet Sites.
Topics: Blood Pressure; Brain Ischemia; Cardiovascular Agents; Critical Care; Disease Management; Humans; Me | 2018 |
Early Achievement of Blood Pressure Lowering and Hematoma Growth in Acute Intracerebral Hemorrhage: Stroke Acute Management with Urgent Risk-Factor Assessment and Improvement-Intracerebral Hemorrhage Study.
Topics: Aged; Antihypertensive Agents; Blood Pressure; Feasibility Studies; Female; Hematoma; Humans; Hypert | 2018 |
Nicardipine Associated Risk of Short-Term Mortality in Critically Ill Patients with Ischemic Stroke.
Topics: Aged; Antihypertensive Agents; Blood Pressure; Brain Ischemia; Critical Illness; Databases, Factual; | 2019 |
Bradycardia caused by intravenous nicardipine in an elderly patient with acute ischemic infarct.
Topics: Aged; Antihypertensive Agents; Bradycardia; Brain Ischemia; Calcium Channel Blockers; Humans; Hypert | 2016 |
Time to Blood Pressure Control Before Thrombolytic Therapy in Patients With Acute Ischemic Stroke: Comparison of Labetalol, Nicardipine, and Hydralazine.
Topics: Adult; Aged; Aged, 80 and over; Antihypertensive Agents; Blood Pressure; Brain Ischemia; Female; Fib | 2015 |
Risk Factors of Nicardipine-Related Phlebitis in Acute Stroke Patients.
Topics: Administration, Intravenous; Aged; Aged, 80 and over; Antihypertensive Agents; Dose-Response Relatio | 2016 |
Overlapping features of eclampsia and postpartum angiopathy.
Topics: Adult; Cerebrovascular Disorders; Eclampsia; Female; Headache; Humans; Methylprednisolone; Nicardipi | 2009 |
Autoregulation after ischaemic stroke.
Topics: Aged; Brain Ischemia; Female; Humans; Male; Middle Aged; Nicardipine; Positron-Emission Tomography; | 2009 |
Refractory caffeine and ergot-induced cervico-cerebral vasospasm and stroke treated with combined medical and endovascular approach.
Topics: Adult; Caffeine; Cerebral Angiography; Dihydroergotamine; Drug Therapy, Combination; Female; Humans; | 2012 |
Retrospective evaluation of nicardipine versus labetalol for blood pressure control in aneurysmal subarachnoid hemorrhage.
Topics: Adult; Aged; Antihypertensive Agents; Blood Pressure; Critical Care; Female; Humans; Hypertension; L | 2012 |
Symptomatic autoregulatory failure in acute ischemic stroke.
Topics: Acute Disease; Antihypertensive Agents; Blood Pressure; Brain; Brain Ischemia; Cerebral Arteries; Ce | 2007 |
Preliminary experience with intra-arterial nicardipine in patients with acute ischemic stroke.
Topics: Adult; Aged; Aged, 80 and over; Angioplasty; Brain Ischemia; Calcium Channel Blockers; Combined Moda | 2007 |
A comparison of nicardipine and labetalol for acute hypertension management following stroke.
Topics: Acute Disease; Aged; Antihypertensive Agents; APACHE; Blood Pressure; Brain Ischemia; Cerebral Hemor | 2008 |