Phase 4
N=1,829
How Effective Are Antithrombotic Therapies in Primary Percutaneous Coronary Intervention
Acute ST Elevation Myocardial Infarction
Bottom Line
View on ClinicalTrials.gov: NCT01519518 ↗Enrolled (actual)
1,829
Serious AEs
—
Results posted
Apr 2015
Primary outcome: 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 percentage of total participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- unfractionated heparin (Drug); Bivalirudin (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Liverpool Heart and Chest Hospital NHS Foundation Trust
- Primary completion
- Dec 2013
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 |
— | — |
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.
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.