A Randomized, Double-Blind, Placebo Controlled, Parallel Group, Multinational Trial, to Assess the Prevention of Thrombotic Events with Ticagrelor Compared to Placebo on a Background of Acetyl Salicylic Acid (ASA) Therapy in Patients with History of Myocardial Infarctio

Phase 3

Completed

• Conditions: atherothrombotic events; obstruction of a coronary artery; 10011082

• Registration Number: NL-OMON39760
• Lead Sponsor: Astra Zeneca

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 6 May 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 700

Inclusion Criteria

- Men and women >50 years of age.
- Person who had a heart attack within 1-3 years ago and at least one additional risk factor:
* Age *65 years
* Diabetes mellitus requiring medication
*Documented history of a second prior presumed spontaneous MI (>1 year ago)
*Documented history of angiographic evidence of multivessel coronary artery disease (CAD)
*Chronic, non-end stage renal dysfunction
- Treated with ASA,
- Females of child-bearing potential must have a negative urine pregnancy test at enrollment and
must be willing to use a medically accepted method of contraception that is considered
reliable in the judgment of the investigator.
- Written informed consent prior to any study specific procedures.

Exclusion Criteria

- Planned use of ADP receptor blockers (eg, clopidogrel, ticlopidine, prasugrel),
dipyridamole, or cilostazol
- Planned coronary, cerebrovascular, or peripheral arterial revascularization
- Concomitant therapy with strong cytochrome P450 3A
(CYP3A) inhibitors, CYP3A substrates with narrow therapeutic indices, or strong
CYP3A inducers.
- Need for chronic oral anticoagulant therapy or chronic low-molecular-weight
heparin
- Patients with known bleeding diathesis or coagulation disorder
- Patients with:
*A history of previous intracranial bleed at any time
*A central nervous system tumour or intracranial vascular abnormality at any time
*Intracranial or spinal cord surgery within 5 years, or
*Gastrointestinal (GI) bleed within the past 6 months, or major surgery within 30 days
- History of ischemic stroke at any time
- Patients considered to be at risk of bradycardic events
- Coronary-artery bypass grafting in the past 5 years, unless the patient has experienced a spontaneous MI subsequent to the bypass surgery
- Known severe liver disease
- Renal failure requiring dialysis
- Pregnancy or lactation
- Life expectancy < 1 year
- Participation in previous study with ticagrelor if treated with ticagrelor.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary efficacy variable is time to first occurrence of any event after<br /><br>randomization from<br /><br>the composite of cardiovascular death, non-fatal MI, or non-fatal stroke.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>(i) Time to occurrence of cardiovascular death after randomization<br /><br>(ii) Time to occurrence of all-cause mortality after randomization</p><br>