Post-treatment PLATelet aggregation-guided therapy FOR ST-segment elevation Myocardial infarctio

Not Applicable

Completed

• Conditions: Acute myocardial infaction with ST elevation; Circulatory System; Acute myocardial infarction

• Registration Number: ISRCTN83081599
• Lead Sponsor: Clinical Center of Serbia (Serbia)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-05-22
• Last Update Posted: 3 July 2017

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 632

Inclusion Criteria

1. Patients with intermediate to high risk for 30-day Major Adverse Cardiac Events (MACE) (RISK-PCI score >3) undergoing primary PCI with stent implantation within 12 hours of the onset of symptoms
2. Ability to comply with study protocol
3. Negative test for pregnancy for women of childbearing potential before enrollment and agreement to use a reliable method of birth control during the study

Exclusion Criteria

Pre-procedural:
1. Any history of hemorrhagic stroke
2. Ischemic stroke within 30 days of randomization
3. Evidence of active abnormal bleeding within 3 months of randomization
4. High risk for bleeding on long-term clopidogrel therapy
5. Current therapy with coumadin anticoagulation
6. Pregnancy or nursing
7. Current enrollment in another investigational drug or device study

Procedural:
1. Balloon angioplasty without stent placement
2. Unsuccessful pPCI (post-procedural TIMI flow 0)

Post-procedural:
1. Died within 24 hours after loading dose
2. Active internal bleeding
3. Hemoglobin < 10 g/dL or drop in hemoglobin by =3 g/dL
4. Platelet count < 100 000 x 10-9/L.
5. Thrombin Receptor Activating Peptide (TRAP) value <500 AU
6. Indication for permanent anticoagulant therapy

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The time to the first of composite events including death, nonfatal infarction, stroke or definite subacute stent thrombosis. Major safety end points includeTIMI major bleeding unrelated to coronary artery bypass graft surgery. Patients will be followed-up after discharge from hospital at 30 days and 1 year after enrolment.

Secondary Outcome Measures

Name	Time	Method
1. Individual components of MACE<br>2. Total bleeding and the need for blood transfusions<br><br>Patients will be followed-up after discharge from hospital at 30 days and 1 year after enrolment.