N/A
N=1,010
Efficacy of Long Term Plavix Therapy Post Angioplasty
Percutaneous Coronary Intervention
Bottom Line
View on ClinicalTrials.gov: NCT02327741 ↗Enrolled (actual)
1,010
Serious AEs
3.4%
Results posted
Apr 2020
Primary outcome: Primary: Number of Patients With Major Bleeding Need Transfusion — 7; 10 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- plavix (Drug)
- Age
- Adult, Older Adult · 50+ yrs
- Sex
- All
- Sponsor
- Shiraz University of Medical Sciences
- Primary completion
- Sep 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Patients With Major Bleeding Need Transfusion |
7; 10 | — |
| PRIMARY Number of Patients With Myocardial Infarction Need Hospital Admission |
5; 7 | — |
| PRIMARY Number of Patients With Central Vascular Accidents Proved by CT Scan |
0; 1 | — |
| PRIMARY Number of Patients With Death Due to Cardiac Causes |
0; 0 | — |
| PRIMARY Revascularization - Need for Redo Bypass Surgery and Redo Angioplasty |
15; 14 | — |
| PRIMARY Number of Patients With Minor Bleeding |
13; 4 | — |
| SECONDARY Tolerability - the Number of Patients , Who Are Able to Take Plavix Concerning Compliance and Economic Issues |
500; 506 | — |
Summary
1010 patients post stenting were enrolled to receive Plavix more than 12 months and less than that and rate of bleeding, complication and major cardiovascular adverse events ( MACE) were compared to evaluate safety and feasibility of long term Plavix therapy post stenting.
Eligibility Criteria
Inclusion Criteria
- post stent ( lesion more than 70% and vessel more than 2.25 mm )
Exclusion Criteria
- allergy to acetylsalicylic acid or clopidogrel,
- planned surgery within 24 months of percutaneous coronary intervention unless the dual antiplatelet therapy could be maintained throughout the perisurgical period
- history of bleeding diathesis
- major surgery within 15 days
- active bleeding
- previous stroke in the past 6 months
- concomitant or foreseeable need for oral anticoagulation therapy
- pregnancy, life expectancy <24 months, participation in another trial
- inability to provide informed consent
Data sourced from ClinicalTrials.gov (NCT02327741). 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.