Antiplatelet Therapy for Bleeding

Phase-Based Progress Estimates
3
Effectiveness
3
Safety
Bleeding+2 More
Oral Anticoagulant plus background antiplatelet therapy - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial is looking at whether adding oral anticoagulation to background antiplatelet therapy is effective and safe in preventing thromboembolic events in patients who develop new-onset atrial fibrillation after isolated coronary artery bypass graft surgery.

Eligible Conditions
  • Bleeding
  • Atrial Fibrillation
  • Stroke

Treatment Effectiveness

Effectiveness Progress

3 of 3
This is further along than 93% of similar trials

Study Objectives

2 Primary · 10 Secondary · Reporting Duration: 90 days after randomization

180 days after randomization
Number of cardiac arrhythmias
Number of participants with MI event
Number of participants with Stroke event
Number of participants with TIA event
Number of participants with systematic arterial thromboembolism event
Number of participants with venous thromboembolism event
90 days after randomization
Any BARC type 3 or 5
Net clinical benefit (NCB)
The incidence of BARC 2 bleeding at 90 days after randomization
Day 180
Transient Ischemic Attack
Number of cardiovascular mortalities
Number of non-cardiovascular mortalities

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Trial Design

2 Treatment Groups

Antiplatelet Therapy
1 of 2
Oral Anticoagulant
1 of 2

Active Control

3200 Total Participants · 2 Treatment Groups

Primary Treatment: Antiplatelet Therapy · No Placebo Group · Phase 4

Antiplatelet Therapy
Drug
ActiveComparator Group · 1 Intervention: Antiplatelet-only strategy · Intervention Types: Drug
Oral Anticoagulant
Drug
ActiveComparator Group · 1 Intervention: Oral Anticoagulant plus background antiplatelet therapy · Intervention Types: Drug

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 90 days after randomization

Who is running the clinical trial?

Vanderbilt University Medical CenterOTHER
768 Previous Clinical Trials
588,956 Total Patients Enrolled
Icahn School of Medicine at Mount SinaiLead Sponsor
773 Previous Clinical Trials
476,741 Total Patients Enrolled
National Heart, Lung, and Blood Institute (NHLBI)NIH
3,577 Previous Clinical Trials
46,965,390 Total Patients Enrolled
1 Trials studying Bleeding
250 Patients Enrolled for Bleeding
John Alexander, MDStudy DirectorDuke University
3 Previous Clinical Trials
2,002 Total Patients Enrolled
Marc Gillinov, MDStudy DirectorThe Cleveland Clinic
5 Previous Clinical Trials
530 Total Patients Enrolled
Annetine C Gelijns, PhDPrincipal InvestigatorIcahn School of Medicine at Mount Sinai
4 Previous Clinical Trials
1,074 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 2 Total Inclusion Criteria

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About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 7th, 2021

Last Reviewed: November 3rd, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.