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COBRA PzF Stenting to Reduce the Duration of Triple Therapy in Patients Treated With Oral Anticoagulation Undergoing Percutaneous Coronary Intervention (COBRA-REDUCE)
The purpose of this study is to determine whether patients undergoing coronary intervention that also require oral anticoagulation, treatment with the COBRA PzF stent plus 14-day dual anti-platelet therapy (DAPT) has higher safety and non-inferior outcomes for thrombo-embolic events than compared with standard FDA-approved drug eluting stent (DES) plus 3 or 6-month DAPT.
Details
| Lead sponsor | CeloNova BioSciences, Inc. |
|---|---|
| Phase | NA |
| Status | UNKNOWN |
| Enrolment | 996 |
| Start date | 2016-02-05 |
| Completion | 2021-11 |
Conditions
- Angina, Stable
- Angina, Unstable
- Anticoagulants
Interventions
- COBRA PzF
- Drug Eluting Stent
Primary outcomes
- BARC class >=2 bleeding after hospital discharge (or beyond 14 days, whichever is "later"). — 6 months
- Composite of all cause death, myocardial infarction, definite and probable stent thrombosis or ischemic stroke — 6 months
Countries
United States, Belgium, Denmark, France, Germany, Italy, Latvia, Switzerland