NCT05223335

Clopidogrel Monotherapy in Patients With High Bleeding Risk

Clopidogrel Monotherapy in High Bleeding Risk Patients Undergoing Percutaneous Coronary Interventions: A Safety Assessment, Pilot Study to Reduce Post-Discharge Bleeding

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 98 (actual)
• Sponsor: Mayo Clinic · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The goal of this research is to show that a shorter duration of two antiplatelet medications (compared to the standard of care) is safe and effective while reducing the risk of bleeding complications. Bleeding complications can cause significant problems (hospitalizations, need for blood transfusions, and even death) for patients on antiplatelet medications after coronary stents. Researchers hope to show that reducing the time on two antiplatelet agents in patients at high risk for these bleeding complications will reduce the number of bleeding events while not causing any increase in cardiovascular complications (heart attack, stent malfunction, death).

Conditions

• Bleeding Complications

Interventions

Type	Name	Description
DRUG	Clopidogrel	75 mg/day
DRUG	Prasugrel	60 mg bolus then 10 mg daily
DRUG	Tricagrelor	180 mg bolus then 90 mg twice daily

Timeline

• Start date: 2022-03-29
• Primary completion: 2023-03-16
• Completion: 2023-03-16
• First posted: 2022-02-03
• Last updated: 2024-02-21
• Results posted: 2024-02-21

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study