ticlopidine and Bradyarrhythmia studies

Ticlopidine: An effective inhibitor of platelet aggregation commonly used in the placement of STENTS in CORONARY ARTERIES.
ticlopidine : A thienopyridine that is 4,5,6,7-tetrahydrothieno[3,2-c]pyridine in which the hydrogen attached to the nitrogen is replaced by an o-chlorobenzyl group.

Research Excerpts

Excerpt	Relevance	Reference
"The aim of this study was to determine whether ticagrelor increased the risk of ventricular pauses compared with clopidogrel and whether these pauses were associated with any clinical bradycardic events in patients presenting with acute coronary syndromes."	9.15	The incidence of bradyarrhythmias and clinical bradyarrhythmic events in patients with acute coronary syndromes treated with ticagrelor or clopidogrel in the PLATO (Platelet Inhibition and Patient Outcomes) trial: results of the continuous electrocardiogr ( Cannon, CP; Emanuelsson, H; Harrington, RA; Husted, S; James, S; Katus, H; Michelson, EL; Pais, P; Raev, D; Scirica, BM; Spinar, J; Steg, PG; Storey, RF; Wallentin, L, 2011)
"Ticagrelor can lower the resting heart rate of patients and cause bradyarrhythmias in the 12th month after PCI."	7.83	Ticagrelor vs. clopidogrel in non-ST-elevation acute coronary syndromes. ( Dong, C; Liu, X; Ren, C; Ren, Q; Zhang, X, 2016)
"The aim of this study was to determine whether ticagrelor increased the risk of ventricular pauses compared with clopidogrel and whether these pauses were associated with any clinical bradycardic events in patients presenting with acute coronary syndromes."	5.15	The incidence of bradyarrhythmias and clinical bradyarrhythmic events in patients with acute coronary syndromes treated with ticagrelor or clopidogrel in the PLATO (Platelet Inhibition and Patient Outcomes) trial: results of the continuous electrocardiogr ( Cannon, CP; Emanuelsson, H; Harrington, RA; Husted, S; James, S; Katus, H; Michelson, EL; Pais, P; Raev, D; Scirica, BM; Spinar, J; Steg, PG; Storey, RF; Wallentin, L, 2011)
"Ticagrelor can lower the resting heart rate of patients and cause bradyarrhythmias in the 12th month after PCI."	3.83	Ticagrelor vs. clopidogrel in non-ST-elevation acute coronary syndromes. ( Dong, C; Liu, X; Ren, C; Ren, Q; Zhang, X, 2016)

Research

Studies (3)

Authors

Clinical Trials (2)

Trial Overview

Trial Outcomes

Participants With Any Event From the Composite of All-cause Mortality, MI, and Stroke

Timeframe	Studies, this research(%)	All Research%
pre-1990	0 (0.00)	18.7374
1990's	0 (0.00)	18.2507
2000's	0 (0.00)	29.6817
2010's	3 (100.00)	24.3611
2020's	0 (0.00)	2.80

Authors	Studies
Tsutsumi, M	1
Aikawa, H	1
Nii, K	1
Etou, H	1
Sakamoto, K	1
Kureshima, M	1
Inoue, R	1
Yoshida, H	1
Matsumoto, Y	1
Narita, S	1
Kazekawa, K	1
Ren, Q	1
Ren, C	1
Liu, X	1
Dong, C	1
Zhang, X	1
Scirica, BM	1
Cannon, CP	1
Emanuelsson, H	1
Michelson, EL	1
Harrington, RA	1
Husted, S	1
James, S	1
Katus, H	1
Pais, P	1
Raev, D	1
Spinar, J	1
Steg, PG	1
Storey, RF	1
Wallentin, L	1

Trial	Phase	Enrollment	Study Type	Start Date	Status
A Randomized, Open-label, Active-controlled, Parallel-group Study to Investigate the Platelet Inhibition of Ticagrelor Versus Clopidogrel in Patients With Stable Coronary Artery Disease and Type 2 Diabetes Mellitus After Recent Elective Percutaneous Coron[NCT02748330]	Phase 4	40 participants (Actual)	Interventional	2016-06-30	Completed
A Randomised, Double-blind, Parallel Group, Phase 3, Efficacy and Safety Study of Ticagrelor Compared With Clopidogrel for Prevention of Vascular Events in Patients With Non-ST or ST Elevation Acute Coronary Syndromes (ACS) [PLATO- a Study of PLATelet Inh[NCT00391872]	Phase 3	18,624 participants (Actual)	Interventional	2006-10-31	Completed
[information is prepared from clinicaltrials.gov, extracted Sep-2024]

Participants with death from any cause, MI, or stroke. If no event, censoring occurs at the earliest of patient withdrawal of consent or date of scheduled withdrawal from therapy. ITT analysis of whole population. Events were adjudicated by an endpoint committee. (NCT00391872)
Timeframe: Randomization up to 12 months

Participants With Any Event From the Composite of Death From Vascular Causes, MI (Including Silent), Stroke, Recurrent Ischemia, Transient Ischemic Attack (TIA) and Other Arterial Thrombotic Events.

Intervention	Participants (Number)
TICAGRELOR	901
CLOPIDOGREL	1065

Participants with death from vascular causes, MI, stroke, recurrent ischemia, or other thrombotic events. If no event, censoring occurs at the earliest of patient withdrawal consent or date of scheduled withdrawal from therapy. ITT analysis of whole population. Events were adjudicated. (NCT00391872)
Timeframe: Randomization up to 12 months

Participants With Any Event From the Composite of Death From Vascular Causes, MI, and Stroke for the Subgroup of Patients With Intent for Invasive Management at Randomization

Intervention	Participants (Number)
TICAGRELOR	1290
CLOPIDOGREL	1456

Participants with death from vascular causes, MI, or stroke. If no event, censoring occurs at the earliest of patient withdrawal consent or date of scheduled withdrawal from therapy. ITT analysis of intent for invasive management population. Events were adjudicated by an endpoint committee. (NCT00391872)
Timeframe: Randomization up to 12 months

Participants With Any Event From the Composite of Death From Vascular Causes, Myocardial Infarction (MI), and Stroke

Intervention	Participants (Number)
TICAGRELOR	569
CLOPIDOGREL	668

Participants with death from vascular causes, MI, or stroke. If no event, censoring occurs at the earliest of patient withdrawal consent or date of scheduled withdrawal from therapy. Intention To Treat (ITT) analysis of whole population. Events were adjudicated by an endpoint committee. (NCT00391872)
Timeframe: Randomization up to 12 months

Participants With Any Major Bleeding Event

Intervention	Participants (Number)
TICAGRELOR	864
CLOPIDOGREL	1014

Participants with major (fatal/life-threatening or other) bleed by a study protocol scale based on need for treatment, number of transfusions, hemoglobin decrease, and other factors. Events were adjudicated by an endpoint committee. (NCT00391872)
Timeframe: First dosing up to 12 months

Participants With Coronary Artery Bypass Graft (CABG) Major Bleeding

Intervention	Participants (Number)
TICAGRELOR	961
CLOPIDOGREL	929

Participants with a major CABG-related bleed by a study protocol scale based on need for treatment, number of transfusions, hemoglobin decrease, and other factors. All CABG surgeries were submitted for adjudication by an endpoint committee as potential bleeds. (NCT00391872)
Timeframe: First dosing up to 12 months

Participants With Coronary Artery Bypass Graft (CABG) Major Fatal/Life-threatening Bleeding

Intervention	Participants (Number)
TICAGRELOR	619
CLOPIDOGREL	654

Number of participants with a major fatal/life-threatening CABG-related bleed by a study protocol scale based on need for treatment, number of transfusions, hemoglobin decrease, and other factors. All CABG surgeries were submitted for adjudication by an endpoint committee as potential bleeds. (NCT00391872)
Timeframe: First dosing up to 12 months

Participants With Death From Any Cause

Intervention	Participants (Number)
TICAGRELOR	329
CLOPIDOGREL	341

Participants with death from any cause. If no event, censoring occurs at the earliest of patient withdrawal consent or date of scheduled withdrawal from therapy. ITT (intention to treat) analysis of whole population. Events were adjudicated by an endpoint committee. (NCT00391872)
Timeframe: Randomization up to 12 months

Participants With Death From Vascular Causes

Intervention	Participants (Number)
TICAGRELOR	399
CLOPIDOGREL	506

Participants with death from vascular causes. If no event, censoring occurs at the earliest of patient withdrawal consent or date of scheduled withdrawal from therapy. ITT (intention to treat) analysis of whole population. Events were adjudicated by an endpoint committee. (NCT00391872)
Timeframe: Randomization up to 12 months

Participants With Major or Minor Bleeding

Intervention	Participants (Number)
TICAGRELOR	353
CLOPIDOGREL	442

Participants with major (fatal/life-threatening or other) or minor bleed by a study protocol scale based on need for treatment, number of transfusions, hemoglobin decrease, and other factors. Events were adjudicated by an endpoint committee. (NCT00391872)
Timeframe: First dosing up to 12 months

Participants With MI Event

Intervention	Participants (Number)
TICAGRELOR	1339
CLOPIDOGREL	1215

Participants with MI event. If no event, censoring occurs at the earliest of patient withdrawal consent or date of scheduled withdrawal from therapy. ITT (intention to treat) analysis of whole population. Events were adjudicated by an endpoint committee. (NCT00391872)
Timeframe: Randomization up to 12 months

Participants With Non-CABG (Coronary Artery Bypass Graft) Related Major Bleeding

Intervention	Participants (Number)
TICAGRELOR	504
CLOPIDOGREL	593

Participants with non CABG related major (fatal/life-threatening or other) bleed by a study protocol scale based on need for treatment, number of transfusions, hemoglobin decrease, and other factors. Events were adjudicated by an endpoint committee. (NCT00391872)
Timeframe: First dosing up to 12 months

Participants With Non-procedural Major Bleeding

Intervention	Participants (Number)
TICAGRELOR	362
CLOPIDOGREL	306

Participants with non-procedural major bleed by a study protocol scale based on need for treatment, number of transfusions, hemoglobin decrease, and other factors. Events were adjudicated by an endpoint committee. (NCT00391872)
Timeframe: First dosing up to 12 months

Participants With Stroke

Intervention	Participants (Number)
TICAGRELOR	235
CLOPIDOGREL	180

Participants with stroke. If no event, censoring occurs at the earliest of patient withdrawal consent or date of scheduled withdrawal from therapy. ITT (intention to treat) analysis of whole population. Events were adjudicated by an endpoint committee. (NCT00391872)
Timeframe: Randomization up to 12 months

Participants With Ventricular Pauses of Greater Than or Equal to 3 Seconds in Patients Monitored by Holter 24 Hour ECG Recorders for 1 Week at 1 Month Following Randomization

Intervention	Participants (Number)
TICAGRELOR	125
CLOPIDOGREL	106

Number of participants who were observed to have at least 1 ventricular pause of at least 3 seconds. Population is all patients who were observed over 2 week-long periods. Pauses were flagged algorithmically and confirmed by TIMI cardiologists. (NCT00391872)
Timeframe: 1-week period following randomization

Participants With Ventricular Pauses of Greater Than or Equal to 3 Seconds in Patients Monitored by Holter 24-hour ECG Recorders for 1 Week Following Randomization

Intervention	Participants (Number)
TICAGRELOR	21
CLOPIDOGREL	16

Number of participants who were observed to have at least 1 ventricular pause of at least 3 seconds. Population is all patients who were observed over 2 week-long periods. Pauses were flagged algorithmically and confirmed by Thrombolysis in Myocardial Infarction (TIMI) group cardiologists. (NCT00391872)
Timeframe: 1-week period following randomization

Article	Year
Cilostazol reduces periprocedural hemodynamic depression in carotid artery stenting. Neurologia medico-chirurgica, 2013, Volume: 53, Issue:3 Topics: Aged; Angioplasty; Bradycardia; Carotid Stenosis; Cilostazol; Clopidogrel; Female; Humans; Hypotensi	2013
The incidence of bradyarrhythmias and clinical bradyarrhythmic events in patients with acute coronary syndromes treated with ticagrelor or clopidogrel in the PLATO (Platelet Inhibition and Patient Outcomes) trial: results of the continuous electrocardiogr Journal of the American College of Cardiology, 2011, May-10, Volume: 57, Issue:19 Topics: Acute Coronary Syndrome; Adenosine; Aged; Bradycardia; Clopidogrel; Electrocardiography; Female; Hum	2011
The incidence of bradyarrhythmias and clinical bradyarrhythmic events in patients with acute coronary syndromes treated with ticagrelor or clopidogrel in the PLATO (Platelet Inhibition and Patient Outcomes) trial: results of the continuous electrocardiogr Journal of the American College of Cardiology, 2011, May-10, Volume: 57, Issue:19 Topics: Acute Coronary Syndrome; Adenosine; Aged; Bradycardia; Clopidogrel; Electrocardiography; Female; Hum	2011
The incidence of bradyarrhythmias and clinical bradyarrhythmic events in patients with acute coronary syndromes treated with ticagrelor or clopidogrel in the PLATO (Platelet Inhibition and Patient Outcomes) trial: results of the continuous electrocardiogr Journal of the American College of Cardiology, 2011, May-10, Volume: 57, Issue:19 Topics: Acute Coronary Syndrome; Adenosine; Aged; Bradycardia; Clopidogrel; Electrocardiography; Female; Hum	2011
The incidence of bradyarrhythmias and clinical bradyarrhythmic events in patients with acute coronary syndromes treated with ticagrelor or clopidogrel in the PLATO (Platelet Inhibition and Patient Outcomes) trial: results of the continuous electrocardiogr Journal of the American College of Cardiology, 2011, May-10, Volume: 57, Issue:19 Topics: Acute Coronary Syndrome; Adenosine; Aged; Bradycardia; Clopidogrel; Electrocardiography; Female; Hum	2011

ticlopidine and Bradyarrhythmia