Phase 3
Completed N=3,602
Harmonizing Outcomes With Revascularization and Stents in Acute Myocardial Infarction
Source: ClinicalTrials.gov NCT00433966 ↗Enrolled (actual)
3,602
Serious AEs
22.6%
Results posted
Dec 2017
Primary outcomePrimary: Pharmacology Arm - Major Adverse Ischemic Cardiac Events and Major Bleeding Events — 166; 218 Participants
◆ Published Evidence
Established
57citations · ~5 / year
Proton Pump Inhibitors, Platelet Reactivity, and Cardiovascular Outcomes After Drug-Eluting Stents in Clopidogrel-Treated Patients: The ADAPT-DES Study.
Summary
The primary objectives of the trial are:
1. To establish the safety and efficacy of the use of bivalirudin (+ bail-out GP IIb/IIIa inhibitors) compared to the use of unfractionated heparin + GP IIb/IIIa inhibitors in patients with acute myocardial infarction undergoing a primary angioplasty strategy.
2. To establish the safety and efficacy of the slow rate release paclitaxel-eluting TAXUS™ stent compared to an otherwise identical uncoated bare metal EXPRESS2™ stent.
Linked Publications (5)
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Proton Pump Inhibitors, Platelet Reactivity, and Cardiovascular Outcomes After Drug-Eluting Stents in Clopidogrel-Treated Patients: The ADAPT-DES Study.
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Utility of post-procedural anticoagulation after primary PCI for STEMI: insights from a pooled analysis of the HORIZONS-AMI and EUROMAX trials.
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Correlation of Admission Heart Rate With Angiographic and Clinical Outcomes in Patients With Right Coronary Artery ST-Segment Elevation Myocardial Infarction Undergoing Primary Percutaneous Coronary Intervention: HORIZONS-AMI (The Harmonizing Outcomes With Revascularization and Stents in Acute Myocardial Infarction) Trial.
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Early Stent Thrombosis and Mortality After Primary Percutaneous Coronary Intervention in ST-Segment-Elevation Myocardial Infarction: A Patient-Level Analysis of 2 Randomized Trials.
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Effect of Short Procedural Duration With Bivalirudin on Increased Risk of Acute Stent Thrombosis in Patients With STEMI: A Secondary Analysis of the HORIZONS-AMI Randomized Clinical Trial.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Pharmacology Arm - Major Adverse Ischemic Cardiac Events and Major Bleeding Events |
166; 218 | — |
| PRIMARY Stent Arm - Ischemic Target Lesion Revascularization |
98; 54 | — |
| PRIMARY Stent Arm - Death, Reinfarction, Stroke, or Stent Thrombosis |
181; 59 | — |
| SECONDARY Pharmacology Arm - Major Adverse Cardiovascular Events |
379; 377 | — |
| SECONDARY Pharmacology Arm - Non-Coronary Artery Bypass Grafting-Related Major Bleeding |
89; 149 | — |
| SECONDARY Stent Arm - Segment Binary Angiographic Restenosis |
102; 76 | — |
| SECONDARY Pharmacology Arm - Major Adverse Cardiovascular Events |
379; 377 | — |
Eligibility Criteria
Inclusion Criteria
- Must have clinical symptoms consistent with AMI (e.g., angina or anginal equivalent)lasting >20 minutes but 1 mm in >2 contiguous leads, or (presumably new) left bundle branch block, or true posterior MI with ST depression of >1 mm in >2 contiguous anterior leads;
- The patient or guardian agrees to the study protocol and the schedule of clinical and angiographic follow-up, and provides informed, written consent.
Exclusion Criteria
- The patient has a known hypersensitivity or contraindication to any of the following medications:
- Heparin, pork or pork products
- Both abciximab and eptifibatide
- Aspirin
- Both Clopidogrel and Ticlopidine
- Bivalirudin
- Paclitaxel or Taxol
- The polymer components of the TAXUS™ stent (SIBS)
- Stainless steel and/or
- Contrast media;
- Prior administration of thrombolytic therapy, bivalirudin, GP IIb/IIIa inhibitors, low molecular weight heparin or fondaparinux for this admission. Patients receiving prior unfractionated heparin may be enrolled, and treated per randomization;
- Current use of coumadin;
- Systemic (intravenous) Paclitaxel or Taxol use within 12 months;
- Female of childbearing potential, unless a recent pregnancy test is negative, who possibly plans to become pregnant any time after enrollment into this study;
- History of bleeding diathesis or known coagulopathy (including heparin-induced thrombocytopenia), or will refuse blood transfusions;
- History of intra-cerebral mass, aneurysm, arteriovenous malformation, or hemorrhagic stroke;
- Stroke or transient ischemic attack within the past 6 months, or any permanent residual neurologic defect;
- Gastrointestinal or genitourinary bleeding within the last 2 months, or major surgery within six weeks;
- Recent history or known current platelet count <100,000 cells/mm3 or Hgb <10 g/dL;
- Extensive peripheral vascular disease, such that emergent angiography and intervention in the opinion of the investigator is likely to be difficult or complicated;
- An elective surgical procedure is planned that would necessitate interruption of thienopyridines during the first six months post enrollment;
- Non-cardiac co-morbid conditions are present with life expectancy <1 year or that may result in protocol non-compliance;
- Patients who are actively participating in another drug or device investigational study, which have not completed the primary endpoint follow-up period;
- Previous enrollment in this trial;
- Patients who underwent coronary stent implantation within the past 30 days.
Data sourced from ClinicalTrials.gov (NCT00433966) and the linked publication. 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.