Phase 4
N=4,614
A Study of Apixaban in Patients With Atrial Fibrillation, Not Caused by a Heart Valve Problem, Who Are at Risk for Thrombosis (Blood Clots) Due to Having Had a Recent Coronary Event, Such as a Heart Attack or a Procedure to Open the Vessels of the Heart
Acute Coronary Syndromes
Bottom Line
View on ClinicalTrials.gov: NCT02415400 ↗Enrolled (actual)
4,614
Serious AEs
4.7%
Results posted
Feb 2020
Primary outcome: Primary: The Rate of International Society on Thrombosis and Haemostasis (ISTH) Major or Clinically Relevant Non-Major (CRNM) Bleeding With Apixaban Versus Vitamin K Antagonist (VKA) During the Treatment Period — 24.66; 35.79 Percentage per year — p=<0.0001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Apixaban (Drug); vitamin K antagonist (Drug); Acetylsalicylic acid (Drug); Acetylsalicylic acid placebo (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Bristol-Myers Squibb
- Primary completion
- Nov 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Rate of International Society on Thrombosis and Haemostasis (ISTH) Major or Clinically Relevant Non-Major (CRNM) Bleeding With Apixaban Versus Vitamin K Antagonist (VKA) During the Treatment Period |
24.66; 35.79 | <0.0001 sig |
| PRIMARY The Rate of ISTH Major or CRNM Bleeding With Aspirin Versus no Aspirin During the Treatment Period |
40.51; 21.03 | <0.0001 sig |
| SECONDARY Superiority on ISTH Major or CRNM Bleeding for Apixaban Versus VKA |
24.66; 35.79 | <0.0001 sig |
| SECONDARY The Rate of All-cause Death or All-cause Rehospitalization With Apixaban Versus VKA |
57.24; 69.19 | 0.0033 sig |
| SECONDARY The Rate of All-cause Death or All-cause Rehospitalization With Aspirn Versus no Aspirin |
65.72; 60.56 | 0.2219 |
| SECONDARY The Rate of the Composite Endpoint of Death or Ischemic Events (Stroke, Myocardial Infarction, Stent Thrombosis, Urgent Revascularization) With Apixaban Versus VKA |
15.85; 17.17 | 0.4370 |
| SECONDARY The Composite Endpoints of Death and Ischemic Events (Stroke, Myocardial Infarction, Stent Thrombosis, Urgent Revascularization) With Aspirin Versus no Aspirin |
15.28; 17.73 | 0.1742 |
Summary
The purpose of this study is to determine if Apixaban is safer than a Vitamin K Antagonist given for 6 months in terms of bleeding in patients with an irregular heart beat (atrial fibrillation) and a recent heart attack or a recent procedure to open up a blood vessel in the heart. All patients would also be taking a class of medicines called P2Y12 inhibitors (such as clopidogrel/Plavix) and be treated for up to 6 months. The primary focus will be a comparison of the bleeding risk of Apixaban, with or without aspirin, versus a Vitamin K antagonist, such as warfarin, with or without aspirin.
Eligibility Criteria
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com
Inclusion Criteria
- Adults with either active or a history of non-valvular atrial fibrillation or flutter with the planned or existing use of an oral anticoagulant for prophylaxis of thromboembolism. In addition, subjects must have had an acute coronary syndrome or percutaneous coronary intervention with a stent within the prior 14 days
- Planned use of antiplatelet agents for at least 1 to 6 months
- Males and Females ≥ 18 years of age
- Women of childbearing potential must have a negative serum or urine pregnancy test within 24 hours prior to the start of study drug
Exclusion Criteria
- Conditions other than atrial fibrillation that require chronic anticoagulation. (e.g. prosthetic mechanical heart valve)
- Severe renal insufficiency (serum creatinine > 2.5 mg/dL or a calculated creatinine clearance < 30 mL/min
- Patients with a history of intracranial hemorrhage
- Patients have had or will undergo Coronary arterial bypass graft (CABG) for their index acute coronary syndrome (ACS) event
- Patients with known ongoing bleeding and patients with known coagulopathies
- Any contraindications or allergies to VKA, apixaban, or to intended P2Y12 antagonists or to aspirin
Data sourced from ClinicalTrials.gov (NCT02415400). 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.