A Comparison of Ticagrelor (AZD6140) and Clopidogrel in Patients With Acute Coronary Syndrome

AstraZeneca18,624 enrolled

Overview

Ticagrelor is a new, reversible binding, anti-platelet medication. Anti-platelet medications work to prevent the formation of blood clots. Ticagrelor is being developed as a treatment for patients with acute coronary syndrome (ACS). ACS is a term that is used to describe both heart attacks in progress or the imminent threat of a heart attack. ACS is usually caused by the formation of a blood clot in an artery that partially or totally blocks the blood supply to a portion of the heart muscle. Ticagrelor will be compared with clopidogrel to determine which drug, when either is used in conjunction with aspirin, is better at reducing deaths from vascular causes, future heart attacks and/or strokes in patients with ACS.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

18,624

Conditions

Acute Coronary Syndrome

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Male or female 18 years or older who has been hospitalised for chest pain and potential ACS * Females of child-bearing potential must have a negative pregnancy test at enrollment and be willing to use 2 methods of reliable contraception Exclusion Criteria: * Persons with moderate or severe liver disease * Persons who have already been treated with an invasive (angioplasty) procedure for the current episode of ACS * Persons who are being treated with blood clotting agents that cannot be stopped

Locations (672)

Research Site

Birmingham, Alabama, United States

Research Site

Huntsville, Alabama, United States

Research Site

Mobile, Alabama, United States

Research Site

Tucson, Arizona, United States

Research Site

Bakersfield, California, United States

Research Site

Outcomes

Primary Outcomes

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

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.

Time frame: Randomization up to 12 months

Participants With Any Major Bleeding Event

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.

Time frame: First dosing up to 12 months

Secondary Outcomes

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

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.

Time frame: Randomization up to 12 months

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

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.

Time frame: 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.

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.

Time frame: Randomization up to 12 months

Participants With MI Event

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.

Time frame: Randomization up to 12 months

Participants With Death From Vascular Causes

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.

Time frame: Randomization up to 12 months

Participants With Stroke

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.

Time frame: Randomization up to 12 months

Participants With Death From Any Cause

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.

Time frame: Randomization up to 12 months

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

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.

Time frame: First dosing up to 12 months

Participants With Major or Minor Bleeding

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.

Time frame: First dosing up to 12 months

Participants With Non-procedural Major Bleeding

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.

Time frame: First dosing up to 12 months

Participants With Coronary Artery Bypass Graft (CABG) Major Bleeding

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.

Time frame: First dosing up to 12 months

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

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.

Time frame: First dosing 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 Following Randomization

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.

Time frame: 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 at 1 Month Following Randomization

Time frame: 1-week period following randomization