Phase 4
Completed N=1,829
How Effective Are Antithrombotic Therapies in Primary Percutaneous Coronary Intervention
Acute ST Elevation Myocardial Infarction
Source: ClinicalTrials.gov NCT01519518 ↗
Enrolled (actual)
1,829
Serious AEs
—
Results posted
Apr 2015
Primary outcomePrimary: Major Adverse Cardiac Events (MACE) in Terms of the Incidence of All Cause Mortality, Cerebrovascular Accident, Re-infarction and Additional Unplanned Target Lesion Revascularization — 5.7; 8.7 percentage of total participants
Summary
The purpose of this study is to compare unfractionated heparin (UFH) and bivalirudin in the performance and subsequent outcomes of Primary percutaneous coronary intervention. This will be a pragmatic trial. Interventional procedures will be performed to reflect current and evolving standards, including predominant radial access. All patients will be treated with routine oral anti-platelet therapy pre-procedure. GP IIb/IIIa inhibitors will be reserved for 'bail out' treatment only.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Major Adverse Cardiac Events (MACE) in Terms of the Incidence of All Cause Mortality, Cerebrovascular Accident, Re-infarction and Additional Unplanned Target Lesion Revascularization |
5.7; 8.7 | — |
| PRIMARY Type 3-5 Bleeding According to BARC (Bleeding Academic Research Consortium)Definition |
3.1; 3.5 | — |
| SECONDARY CKMB Release Following Index Revascularisation Measured With a Single Estimation 12-18 Hours After the Procedure |
— | — |
| SECONDARY Minor Bleeding: Type 2 Bleeding According to BARC (Bleeding Academic Research Consortium) Definition |
10.8; 9.2 | — |
| SECONDARY Stent Thrombosis Rate (ARC Definite or Probable) |
0.9; 3.4 | — |
| SECONDARY For Illustration, and to Allow Comparison With Existing Trials the Rate of Net Adverse Clinical Events (NACE), Combining the Primary Safety and Efficacy Outcomes |
— | — |
| SECONDARY All Cause Mortality |
— | — |
| SECONDARY Development of Thrombocytopenia |
— | — |
| SECONDARY Door-to-first Device Time |
— | — |
Eligibility Criteria
Inclusion Criteria
- All patients presenting with a suspected myocardial infarction event with PPCI as the proposed index reperfusion strategy will be included in the trial
Exclusion Criteria
- ≤ 18 years of age
- Known intolerance, hypersensitivity or contraindication to any trial medication
- Active bleeding at presentation
- Artificial ventilation, reduced conscious level or other factors precluding the administration of oral antiplatelet therapy
- Previous enrolment in this trial
Data sourced from ClinicalTrials.gov (NCT01519518). 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. Informational only — not medical advice.