aspirin and Neoplasms

aspirin has been researched along with Neoplasms in 479 studies

Aspirin: The prototypical analgesic used in the treatment of mild to moderate pain. It has anti-inflammatory and antipyretic properties and acts as an inhibitor of cyclooxygenase which results in the inhibition of the biosynthesis of prostaglandins. Aspirin also inhibits platelet aggregation and is used in the prevention of arterial and venous thrombosis. (From Martindale, The Extra Pharmacopoeia, 30th ed, p5)
acetylsalicylate : A benzoate that is the conjugate base of acetylsalicylic acid, arising from deprotonation of the carboxy group.
acetylsalicylic acid : A member of the class of benzoic acids that is salicylic acid in which the hydrogen that is attached to the phenolic hydroxy group has been replaced by an acetoxy group. A non-steroidal anti-inflammatory drug with cyclooxygenase inhibitor activity.

Neoplasms: New abnormal growth of tissue. Malignant neoplasms show a greater degree of anaplasia and have the properties of invasion and metastasis, compared to benign neoplasms.

Research

Studies (479)

Authors

Clinical Trials (31)

Trial Overview

Trial Outcomes

All-cause Mortality

Count of participants and time from randomization to death by all cause were evaluated. Hazard ratios were calculated and reported as statistical analysis. (NCT01776424)
Timeframe: For each participants, death by any cause after randomization up until the global rivaroxaban/aspirin outcomes cut-off date (06 FEB 2017) was considered. The mean time in follow-up until that date was 702 days.

All-cause Mortality in LTOLE Part

Count of participants from COMPASS LTOLE initiation visit to death by all cause were evaluated. LTOLE: long-term open-lable extension (NCT01776424)
Timeframe: For each participants, death by any cause after COMPASS LTOLE initiation visit up until the the last LTOLE part contact date was considered. The mean time in follow-up until that date was 428 days.

The First Occurrence of MI, Ischemic Stroke, ALI, or Cardiovascular (CV) Death

Count of participants and time from randomization to the first occurrence of MI, ischemic stroke, ALI, or CV death were evaluated. Hazard ratios were calculated and reported as statistical analysis. (NCT01776424)
Timeframe: For each participant, the first occurrence of MI, ischemic stroke, ALI, or CV death after randomization up until the global rivaroxaban/aspirin outcomes cut-off date (06 FEB 2017) was considered. The mean time in follow-up until that date was 702 days.

The First Occurrence of Myocardial Infarction (MI), Ischemic Stroke, Acute Limb Ischemia (ALI), or Coronary Heart Disease (CHD) Death

Count of participants and time from randomization to the first occurrence of MI, ischemic stroke, ALI, or CHD death were evaluated. Hazard ratios were calculated and reported as statistical analysis. (NCT01776424)
Timeframe: For each participant, the first occurrence of MI, ALI, or CHD death after randomization up until the global rivaroxaban/aspirin outcomes cut-off date (06 FEB 2017) was considered. The mean time in follow-up until that date was 702 days.

The First Occurrence of the Composite Primary Efficacy Outcome, Myocardial Infarction (MI), Stroke, or Cardiovascular (CV) Death

Count of participants and time from randomization to the first occurrence of the composite primary efficacy outcome, MI, stroke, or CV death were evaluated. Hazard ratios were calculated and reported as statistical analysis. (NCT01776424)
Timeframe: For each participant, the first occurrence of the composite primary efficacy outcome after randomization up until the global rivaroxaban/aspirin outcomes cut-off date (06 FEB 2017) was considered. The mean time in follow-up until that date was 702 days.

The First Occurrence of the Composite Primary Efficacy Outcome, Myocardial Infarction (MI), Stroke, or Cardiovascular (CV) Death in LTOLE Part

Count of participants from COMPASS LTOLE initiation visit to the first occurrence of the composite primary efficacy outcome, MI, stroke, or CV death were evaluated. LTOLE: long-term open-lable extension (NCT01776424)
Timeframe: For each participant, the first occurrence of the composite primary efficacy outcome after from COMPASS LTOLE initiation visit up until last LTOLE part contact date was considered. The mean time in follow-up was 428 days.

The First Occurrence of the Primary Safety Outcome Major Bleeding Based on a Modification of the International Society on Thrombosis and Haemostasis (ISTH) Criteria

"Modified ISTH major bleeding is defined as: i) Fatal bleeding, or ii) Symptomatic bleeding in a critical area or organ, such as intraarticular, intracranial, intramuscular with compartment syndrome, intraocular, intraspinal, liver, pancreas, pericardial, respiratory, retroperitoneal, adrenal gland or kidney; or bleeding into the surgical site requiring reoperation, or iii) Bleeding leading to hospitalization (major bleeding also includes presentation to an acute care facility with discharge on the same day).~Count of participants and time from randomization to the first occurrence of the primary safety outcome major bleeding were evaluated. Hazard ratios were calculated and reported as statistical analysis." (NCT01776424)
Timeframe: For each participant, the first occurrence of modified ISTH major bleeding after randomization up until the global rivaroxaban/aspirin outcomes cut-off date (06 FEB 2017) was considered. The mean time in follow-up until that date was 702 days.

The First Occurrence of the Primary Safety Outcome Major Bleeding Based on a Modification of the International Society on Thrombosis and Haemostasis (ISTH) Criteria in LTOLE Part

"Modified ISTH major bleeding is defined as: i) Fatal bleeding, or ii) Symptomatic bleeding in a critical area or organ, such as intraarticular, intracranial, intramuscular with compartment syndrome, intraocular, intraspinal, liver, pancreas, pericardial, respiratory, retroperitoneal, adrenal gland or kidney; or bleeding into the surgical site requiring reoperation, or iii) Bleeding leading to hospitalization (major bleeding also includes presentation to an acute care facility with discharge on the same day).~Count of participants from COMPASS LTOLE initiation visit to the first occurrence of the primary safety outcome major bleeding was evaluated. LTOLE: long-term open-lable extension" (NCT01776424)
Timeframe: For each participant, the first occurrence of modified ISTH major bleeding from COMPASS LTOLE initiation visit up until 2 days after the last treatment in LTOLE part was considered. The mean time in follow-up was 421 days.

Incidence Rate of a Major Bleeding Event According to the International Society on Thrombosis and Haemostasis (ISTH) Criteria (Adjudicated)

Major bleeding event (as per ISTH), defined as bleeding event that met at least one of following: fatal bleeding; symptomatic bleeding in a critical area or organ (intraarticular, intramuscular with compartment syndrome, intraocular, intraspinal, pericardial, or retroperitoneal); symptomatic intracranial haemorrhage; clinically overt bleeding associated with a recent decrease in the hemoglobin level of greater than or equal to (>=) 2 grams per decilitre (g/dL) (20 grams per liter [g/L]; 1.24 millimoles per liter [mmol/L]) compared to the most recent hemoglobin value available before the event; clinically overt bleeding leading to transfusion of 2 or more units of packed red blood cells or whole blood. The results were based on classification of events that have been positively adjudicated as major bleeding events. Incidence rate estimated as number of subjects with incident events divided by cumulative at-risk time, where subject is no longer at risk once an incident event occurred. (NCT02313909)
Timeframe: From randomization until the efficacy cut-off date (median 326 days)

Incidence Rate of All-Cause Mortality

All-cause mortality includes all deaths of participants due to any cause. (NCT02313909)
Timeframe: From randomization until the efficacy cut-off date (median 326 days)

Incidence Rate of Any of the Following: Cardiovascular Death, Recurrent Stroke, Systemic Embolism and Myocardial Infarction

Incidence rate estimated as number of participants with incident events divided by cumulative at-risk time, where participant is no longer at risk once an incident event occurred. Cardiovascular death includes death due to hemorrhage and death with undetermined/unknown cause. Systemic embolism is defined as abrupt vascular insufficiency associated with clinical or radiological evidence of arterial occlusion in the absence of other likely mechanisms. The diagnosis of myocardial infarction requires the combination of: 1)evidence of myocardial necrosis (either changes in cardiac biomarkers or post-mortem pathological findings); and 2)supporting information derived from the clinical presentation, electrocardiographic changes, or the results of myocardial or coronary artery imaging. (NCT02313909)
Timeframe: From randomization until the efficacy cut-off date (median 326 days)

Incidence Rate of Clinically Relevant Non-Major Bleeding Events

Non-major clinically relevant bleeding was defined as non-major overt bleeding but required medical attention (example: hospitalization, medical treatment for bleeding), and/or was associated with the study drug interruption of more than 14 days. The results were based on the outcome events at or after randomization until the efficacy cut-off date. Incidence rate estimated as number of participants with incident events divided by cumulative at-risk time, where participant is no longer at risk once an incident event occurred. (NCT02313909)
Timeframe: From randomization until the efficacy cut-off date (median 326 days)

Incidence Rate of Intracranial Hemorrhage

Intracranial hemorrhage included all bleeding events that occurred in intracerebral, sub arachnoidal as well as subdural or epidural sites. The below table displays results for all randomized participants and the outcomes at or after randomization until the efficacy cut-off date. Incidence rate estimated as number of participants with incident events divided by cumulative at-risk time, where participant is no longer at risk once an incident event occurred. (NCT02313909)
Timeframe: From randomization until the efficacy cut-off date (median 326 days)

Incidence Rate of Life-Threatening Bleeding Events

Life-threatening bleeding was defined as a subset of major bleeding that met at least one of the following criteria: 1) fatal bleeding; 2) symptomatic intracranial haemorrhage; 3) reduction in hemoglobin of at least 5 g/dl (50 g/l; 3.10 mmol/L); 4) transfusion of at least 4 units of packed red cells or whole blood; 5) associated with hypotension requiring the use of intravenous inotropic agents; 6) necessitated surgical intervention. Incidence rate estimated as number of participants with incident events divided by cumulative at-risk time, where participant is no longer at risk once an incident event occurred. (NCT02313909)
Timeframe: From randomization until the efficacy cut-off date (median 326 days)

Incidence Rate of the Composite Efficacy Outcome (Adjudicated)

Components of composite efficacy outcome (adjudicated) includes stroke (ischemic, hemorrhagic, and undefined stroke, TIA with positive neuroimaging) and systemic embolism. Incidence rate estimated as number of participants with incident events divided by cumulative at-risk time, where participant is no longer at risk once an incident event occurred. (NCT02313909)
Timeframe: From randomization until the efficacy cut-off date (median 326 days)

Incidence Rate of the Following: Stroke, Ischemic Stroke, Disabling Stroke, Cardiovascular (CV) Death, Myocardial Infarction

"Disabling stroke is defined as stroke with modified Rankin score (mRS) greater than or equal to (>=) 4 as assessed by investigator. mRS spans 0-6, running from perfect health to death. A score of 0-3 indicates functional status ranging from no symptoms to moderate disability (defined in the mRS as requiring some help, but able to walk without assistance); mRS 4-6 indicates functional status ranging from moderately severe disability (unable to walk or to attend to own bodily needs without assistance)through to death. CV death includes death due to hemorrhage and death with undetermined/unknown cause. Diagnosis of myocardial infarction requires combination of: 1) evidence of myocardial necrosis either changes in cardiac biomarkers or post-mortem pathological findings); 2) supporting information derived from clinical presentation, electrocardiographic changes, or results of myocardial or coronary artery imaging." (NCT02313909)
Timeframe: From randomization until the efficacy cut-off date (median 326 days)

Number of Participants Who Experienced Death or Myocardial Infarction (MI)

Rate of death or myocardial infarction (NCT02605447)
Timeframe: 3 to 15 months

Number of Participants Who Experienced Major Bleeding

"Rate of Bleeding, per Bleeding Academic Consortium definition (BARC2, 3a, 3b, 3c, 4, 5a and 5b)~Type 0: No Bleeding~Type 1: Bleeding that is not actionable and does not cause the patient to seek treatment~Type 2: Any clinically overt sign of hemorrhage that is actionable and requires diagnostic studies, hospitalization, or treatment by a health care professional~Type 3a: Overt bleeding plus hemoglobin drop of 3 to < 5 g/dL (provided hemoglobin drop is related to bleed); transfusion with overt bleeding~Type 3b: Overt bleeding plus hemoglobin drop ≥5 g/dL (provided hemoglobin drop is related to bleed); cardiac tamponade; bleeding requiring surgical intervention for control; bleeding requiring IV vasoactive agents~Type 3c: Intracranial hemorrhage confirmed by autopsy, imaging, or lumbar puncture; intraocular bleed compromising vision~Type 4: CABG-related bleeding within 48 hours~Type 5a: Probable fatal bleeding~Type 5b: Definite fatal bleeding" (NCT02605447)
Timeframe: 3 to 15 months

Number of Participants Who Experienced Stent Thrombosis (ST)

"Rate of stent thrombosis: definite + probable, using the Academic Research Consortium (ARC) definition Confirmed/Definite (is considered either angiographic confirmed or pathologic confirmed) Probable~Clinical definition of probable stent thrombosis is considered to have occurred in the following cases:~Any unexplained death within the first 30 days~Irrespective of the time after the index procedure and MI in the absence of any obvious cause which is related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation of stent thrombosis Possible Clinical definition of possible stent thrombosis is considered to have occurred with any unexplained death beyond 30 days." (NCT02605447)
Timeframe: 3 to 15 months

Number of Participants With Cancer, Excluding Nonmelanoma Skin Cancer

(NCT00000479)
Timeframe: Average follow-up 10.1 years

Number of Participants With Major Cardiovascular Events (a Combined Endpoint of Nonfatal Myocardial Infarction, Nonfatal Stroke, and Total Cardiovascular Death)

(NCT00000479)
Timeframe: Average follow-up 10.1 years

Definite or Probable Stent Thrombosis (ST) - Propensity Matched DES vs. BMS

Secondary powered endpoint (NCT00977938)
Timeframe: 33 months (0-33 months post-index procedure)

Definite or Probable Stent Thrombosis (ST) - Randomized BMS ITT

ST was assessed according to the Academic Research Consortium (ARC) definitions. (NCT00977938)
Timeframe: 18 months (12-30 months post-index procedure)

Definite or Probable Stent Thrombosis (ST) - Randomized BMS ITT

ST was assessed according to the Academic Research Consortium (ARC) definitions. (NCT00977938)
Timeframe: 21 months (12-33 months post-index procedure)

Definite or Probable Stent Thrombosis (ST) - Randomized DES ITT

ST was assessed according to the Academic Research Consortium (ARC) definitions. (NCT00977938)
Timeframe: 21 months (12-33 months post-index procedure)

Definite or Probable Stent Thrombosis (ST) - Randomized DES ITT

The coprimary efficacy endpoints were the cumulative incidence of MACCE and the cumulative incidence of definite or probable ST within randomized DES ITT patients between 12 and 30 months post procedure. ST was assessed according to the Academic Research Consortium (ARC) definitions. (NCT00977938)
Timeframe: 18 months (12-30 months post-index procedure)

GUSTO Severe or Moderate Bleeding - Randomized BMS ITT

Bleeding was assessed according to the Global Utilization of Streptokinase and Tissue Plasminogen Activator for Occluded Arteries (GUSTO) criteria. (NCT00977938)
Timeframe: 18 months (12-30 months post-index procedure)

GUSTO Severe or Moderate Bleeding - Randomized BMS ITT

Bleeding was assessed according to the Global Utilization of Streptokinase and Tissue Plasminogen Activator for Occluded Arteries (GUSTO) criteria. (NCT00977938)
Timeframe: 21 months (12-33 months post-index procedure)

GUSTO Severe or Moderate Bleeding - Randomized DES ITT

Bleeding was assessed according to the Global Utilization of Streptokinase and Tissue Plasminogen Activator for Occluded Arteries (GUSTO) criteria. (NCT00977938)
Timeframe: 21 months (12-33 months post-index procedure)

GUSTO Severe or Moderate Bleeding - Randomized DES ITT

The primary safety endpoint was moderate or severe bleeding within randomized DES ITT patients between 12 and 30 months post procedure. Bleeding was assessed according to the Global Utilization of Streptokinase and Tissue Plasminogen Activator for Occluded Arteries (GUSTO) criteria. (NCT00977938)
Timeframe: 18 months (12-30 months post-index procedure)

MACCE (Death, Myocardial Infarction or Stroke) - Propensity Matched DES vs. BMS

Secondary powered endpoint (NCT00977938)
Timeframe: 33 months (0-33 months post-index procedure)

MACCE (Death, Myocardial Infarction or Stroke) - Randomized BMS ITT

(NCT00977938)
Timeframe: 18 months (12-30 months post-index procedure)

MACCE (Death, Myocardial Infarction or Stroke) - Randomized BMS ITT

(NCT00977938)
Timeframe: 21 months (12-33 months post-index procedure)

MACCE (Death, Myocardial Infarction or Stroke) - Randomized DES ITT

(NCT00977938)
Timeframe: 21 months (12-33 months post-index procedure)

MACCE (Death, Myocardial Infarction or Stroke) - Randomized DES ITT

The coprimary efficacy endpoints were the cumulative incidence of MACCE and the cumulative incidence of ARC definite or probable stent thrombosis within randomized DES ITT patients between 12 and 30 months post procedure. (NCT00977938)
Timeframe: 18 months (12-30 months post-index procedure)

Adverse Experiences: Anxiety

Number of participants with anxiety (NCT00740714)
Timeframe: Over 16 months (Screening, Baseline, 1, 4, 8, 12 and 16 month visits)

Adverse Experiences: Anxiety: Moderate/Severe

Number of participants with moderate/severe anxiety (NCT00740714)
Timeframe: Over 16 months (Screening, Baseline, 1, 4, 8, 12 and 16 month visits)

Adverse Experiences: Back Pain

Number of participants with back pain (NCT00740714)
Timeframe: Over 16 months (Screening, Baseline, 1, 4, 8, 12 and 16 month visits)

Adverse Experiences: Back Pain: Moderate/Severe

Number of participants with moderate/severe back pain (NCT00740714)
Timeframe: Over 16 months (Screening, Baseline, 1, 4, 8, 12 and 16 month visits)

Adverse Experiences: Constipation

Number of participants with constipation (NCT00740714)
Timeframe: Over 16 months (Screening, Baseline, 1, 4, 8, 12 and 16 month visits)

Adverse Experiences: Constipation: Moderate/Severe

Number of participants with moderate/severe constipation (NCT00740714)
Timeframe: Over 16 months (Screening, Baseline, 1, 4, 8, 12 and 16 month visits)

Adverse Experiences: Depression

Number of participants with depression (NCT00740714)
Timeframe: Over 16 months (Screening, Baseline, 1, 4, 8, 12 and 16 month visits)

Adverse Experiences: Diarrhoea

Number of participants with diarrhoea (NCT00740714)
Timeframe: Over 16 months (Screening, Baseline, 1, 4, 8, 12 and 16 month visits)

Adverse Experiences: Headache

Number of participants with headache (NCT00740714)
Timeframe: Over 16 months (Screening, Baseline, 1, 4, 8, 12 and 16 month visits)

Adverse Experiences: Hypertension

Number of participants with hypertension (NCT00740714)
Timeframe: Over 16 months (Screening, Baseline, 1, 4, 8, 12 and 16 month visits)

Adverse Experiences: Insomnia

Number of participants with insomnia (NCT00740714)
Timeframe: Over 16 months (Screening, Baseline, 1, 4, 8, 12 and 16 month visits)

Adverse Experiences: Insomnia: Moderate/Severe

Number of participants with moderate/severe insomnia (NCT00740714)
Timeframe: Over 16 months (Screening, Baseline, 1, 4, 8, 12 and 16 month visits)

Adverse Experiences: Nasopharyngitis

Number of participants with nasopharyngitis (NCT00740714)
Timeframe: Over 16 months (Screening, Baseline, 1, 4, 8, 12 and 16 month visits)

Adverse Experiences: Nausea

Number of participants with nausea (NCT00740714)
Timeframe: Over 16 months (Screening, Baseline, 1, 4, 8, 12 and 16 month visits)

Adverse Experiences: Tremor

Number of participants with tremor (NCT00740714)
Timeframe: Over 16 months (Screening, Baseline, 1, 4, 8, 12 and 16 month visits)

Adverse Experiences: Urinary Tract Infection

Number of patients with urinary tract infections (NCT00740714)
Timeframe: Over 16 months (Screening, Baseline, 1, 4, 8, 12 and 16 month visits)

Change in Hoehn & Yahr Score From Baseline to 16 Months

The Modified Hoehn and Yahr Scale is an 8-level Parkinson disease staging instrument. The investigator will assess disease stage at each level. The disease stages range from the best outcome of 0 (no signs of disease) to the worst outcome of 5 (wheelchair bound or bedridden unless aided). (NCT00740714)
Timeframe: Baseline to 16 months or the time of sufficient disability to require dopaminergic therapy or study closure, whichever occurs first

Change in Modified Rankin Scale From Baseline to 16 Months

The Modified Rankin Scale is a global functional health index with a strong accent on physical disability. Subjects are scored on a scale of 0 (no symptoms at all) to 5 (severe disability: bedridden incontinent, and requiring constant nursing care and attention. (NCT00740714)
Timeframe: Baseline to 16 months or the time of sufficient disability to require dopaminergic therapy or study closure, whichever occurs first

Change in Modified Schwab & England Independence Scale From Baseline to 16 Months

This scale measures activities of daily living. This is an investigator and subject assessment of the subject's level of independence at all scheduled visits. The subject is scored on a percentage scale reflective of his/her ability to perform acts of daily living in relation to pre-Parkinson disease ability. Scores range in increments of 10%: 100% for normal (subject is completely independent; essentially normal) to 0% (vegetative functions such as swallowing, bladder and bowel functions are not functioning; bedridden). (NCT00740714)
Timeframe: Baseline to 16 months or the time of sufficient disability to require dopaminergic therapy or study closure, whichever occurs first

Change in PD Quality of Life Scale From Baseline to 16 Months

The subject will complete a questionnaire that will evaluate how Parkinson disease has affected their health and overall quality of life at each visit. The total quality of life scale measures a total of 33 aspects of quality of life. Each aspect is rated on scale of 0 (best outcome) to 4 (worst outcome). Total score range is 0-132. A higher score or increased score compared to a previous visit indicates a lowered quality of life. (NCT00740714)
Timeframe: Baseline to 16 months or the time of sufficient disability to require dopaminergic therapy or study closure, whichever occurs first

Change in Symbol Digit Modalities Test From Baseline to 16 Months

The Symbol Digit Modalities Test screens cognitive impairment by using a simple substitution tasks that individuals with normal functioning can easily perform. The test score range is from 0(worst outcome) to 110 (best outcome). (NCT00740714)
Timeframe: Baseline to 16 months or the time of sufficient disability to require dopaminergic therapy or study closure, whichever occurs first

Change in Unified Parkinson's Disease Rating Scale (UPDRS) (Total Score (Sum of Parts I, II and III Ranges From 0 to 176))

Outcome is defined as change in total Unified Parkinson's Disease Rating Scale (UPDRS) between the baseline visit and month 16 or the time of sufficient disability to require dopaminergic therapy or study closure, whichever occurs first. The UPDRS score has three components, each consisting of questions answered on a 0-4 point scale. Part I assesses mentation, behavior and mood; Part II assesses activities of daily living in the week prior to the designated visit; and Part III assesses motor abilities at the time of the visit. A total of 31 items are included in Parts I, II and III. Each item will receive a score ranging from 0 to 4 where 0 represents the absence of impairment and 4 represents the highest degree of impairment. Total score ranges from 0-176. (NCT00740714)
Timeframe: Baseline to 16 months or the time of sufficient disability to require dopaminergic therapy or study closure, whichever occurs first

CoQ10 Levels in Plasma

Based on samples analyzed to date (NCT00740714)
Timeframe: Baseline, 1, 8 and 16 months or the time of sufficient disability to require dopaminergic therapy or study closure, whichever occurs first

Reviews

142 reviews available for aspirin and Neoplasms