Completed
PHASE3
INTERVENTIONAL
NCT01225562
Prevention of Cardiovascular Events (eg, Death From Heart or Vascular Disease, Heart Attack, or Stroke) in Patients With Prior Heart Attack Using Ticagrelor Compared to Placebo on a Background of Aspirin
View on ClinicalTrials.gov
Updated Dec 15, 2025
Brief Summary
This study is being carried out to see if a new drug called ticagrelor given twice daily in addition to the ASA therapy decreases the frequency of cardiovascular events (e.g., death from heart disease, heart attack, or stroke).
Interventions
Name:
Ticagrelor 90 mg
Type:
DRUG
Description:
Oral dose twice a day
Name:
Ticagrelor 60 mg
Type:
DRUG
Description:
Oral dose twice a day
Name:
Ticagrelor Placebo
Type:
DRUG
Description:
Oral dose twice a day
Primary Outcomes
Measure:
Kaplan-Meier Estimate of the Percentage of Patients Who Experienced Cardiovascular Death (CV Death), Myocardial Infarction (MI) or Stroke Within 3 Years From Randomization
TimeFrame:
Randomization up to 47 months
Description:
Participants with CV death, MI or Stroke. If no event, censoring occurs at the earliest of the efficacy cut-off date 14 Sep 2014, withdrawal of consent, non-CV death or at the last time point of complete clinical event assessment. Events were adjudicated by a blinded endpoint committee. The Kaplan-Meier estimate reports the percentage of patients who experienced CV Death, MI or stroke within 3 years from randomization
Measure:
Kaplan-Meier Estimate of the Percentage of Patients Who Experienced a TIMI Major Bleeding Within 3 Years From First Dose of Study Drug Units: Percentage of Patients
TimeFrame:
First dosing up to 48 months
Description:
A Thrombolysis in Myocardial Infarction (TIMI) study group major bleeding is defined as any fatal bleeding (leading directly to death within 7 days), any intrcranial bleeding or any clinically overt signs of haemorrhage associated with a drop in Haemoglobin of \>= 5g/dL. Events were adjudicated by a clinical events committee. Censoring ocurrs at 7 days following last dose of study drug. The Kaplan-Meier estimate reports the percentage of patients who experienced a TIMI Major bleeding within 3 years from first dose of study drug
Trial Information
NCT ID
NCT01225562
Status
Completed
Study Type
INTERVENTIONAL
Phases
PHASE3
Sponsor
AstraZeneca
Last Updated
December 15, 2025