Phase 3 N=18,624 Randomized Quadruple-blind Treatment

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

Acute Coronary Syndrome

Bottom Line

View on ClinicalTrials.gov: NCT00391872 ↗

Enrolled (actual)

18,624

Serious AEs

—

Results posted

Mar 2012

Primary outcome: Primary: Participants With Any Event From the Composite of Death From Vascular Causes, Myocardial Infarction (MI), and Stroke — 864; 1014 Participants

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Ticagrelor (Drug); Clopidogrel (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: AstraZeneca
Primary completion: Mar 2009

Outcome Measures

Outcome	Result	p-value
PRIMARY Participants With Any Event From the Composite of Death From Vascular Causes, Myocardial Infarction (MI), and Stroke	864; 1014	—
PRIMARY Participants With Any Major Bleeding Event	961; 929	—
SECONDARY 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	569; 668	—
SECONDARY Participants With Any Event From the Composite of All-cause Mortality, MI, and Stroke	901; 1065	—
SECONDARY 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.	1290; 1456	—
SECONDARY Participants With MI Event	504; 593	—
SECONDARY Participants With Death From Vascular Causes	353; 442	—
SECONDARY Participants With Stroke	125; 106	—
SECONDARY Participants With Death From Any Cause	399; 506	—
SECONDARY Participants With Non-CABG (Coronary Artery Bypass Graft) Related Major Bleeding	362; 306	—
SECONDARY Participants With Major or Minor Bleeding	1339; 1215	—
SECONDARY Participants With Non-procedural Major Bleeding	235; 180	—
SECONDARY Participants With Coronary Artery Bypass Graft (CABG) Major Bleeding	619; 654	—
SECONDARY Participants With Coronary Artery Bypass Graft (CABG) Major Fatal/Life-threatening Bleeding	329; 341	—
SECONDARY 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	84; 51	—
SECONDARY 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	21; 16	—

Summary

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.

Eligibility Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00391872). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.