Clopidogrel Monotherapy in Patients With High Bleeding Risk

Sponsor
Mayo Clinic (Other)
Overall Status
Recruiting
CT.gov ID
NCT05223335
Collaborator
(none)
100
1
2
23.1
4.3

Study Details

Study Description

Brief 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).

Condition or Disease Intervention/Treatment Phase
Phase 4

Study Design

Study Type:
Interventional
Anticipated Enrollment :
100 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Clopidogrel Monotherapy in High Bleeding Risk Patients Undergoing Percutaneous Coronary Interventions: A Safety Assessment, Pilot Study to Reduce Post-Discharge Bleeding
Actual Study Start Date :
Mar 29, 2022
Anticipated Primary Completion Date :
Mar 1, 2023
Anticipated Study Completion Date :
Mar 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Genotype-Guided Therapy

Subjects with high bleeding risk (HBR) on dual antiplatelet therapy (DAPT) with clopidogrel and aspirin, that have undergone successful percutaneous coronary intervention (PCI) will be stratified by the CYP2C19 LOF allele within one week of DAPT initiation. In this group, subjects identified as CYP2C19*2 or*3 LOF allele carrier will be given prasugrel or ticagrelor monotherapy.

Drug: Prasugrel
60 mg bolus then 10 mg daily

Drug: Tricagrelor
180 mg bolus then 90 mg twice daily

Active Comparator: Conventional Therapy

Subjects with high bleeding risk (HBR) on dual antiplatelet therapy (DAPT) with clopidogrel and aspirin, that have undergone successful percutaneous coronary intervention (PCI) will be stratified by the CYP2C19 LOF allele within one week of DAPT initiation. In this group, subjects identified as CYp2C19*2 or*3 LOF allele non-carriers will continue with clopidogrel monotherapy.

Drug: Clopidogrel
75 mg/day

Outcome Measures

Primary Outcome Measures

  1. Ischemic risk post-PCI in high bleed risk patients with genotype-guided single antiplatelet therapy [Through study completion, approximately 90 days.]

    The number of participants to experience ischemic events as defined as cardiac deaths, spontaneous myocardial infarctions (MIs) and stent thrombosis after percutaneous intervention (PCI).

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Informed consent in adults

  • Successful percutaneous coronary intervention (PCI) [no non-fatal MI/stroke/repeat target revascularization/bleeding/acute kidney injury].

  • Academic research consortium-high bleeding risk (ARC-HBR) score ≥ 4.

Exclusion Criteria:
  • Chronic use of warfarin or direct oral anticoagulant (DOAC).

  • Unsuccessful PCI (see above).

  • Lesions with angiographic thrombus.

  • Prior PCI within 6 months.

  • Planned PCI or surgical intervention to treat any cardiac or noncardiac condition within 6 months.

  • High risk lesion/stent characteristics (> 50% unprotected left main disease, bifurcation disease requiring 2 stents technique, rotational atherectomy.

  • Vein graft.

  • Unprotected left main intervention or history of definite stent thrombosis.

  • Women of child-bearing age unless negative pregnancy test is done.

  • Life expectancy < 1 year.

  • Known drug/alcohol dependence.

  • Assessment that the patient will not be compliant with the study protocol.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Mayo Clinic in Rochester Rochester Minnesota United States 55905

Sponsors and Collaborators

  • Mayo Clinic

Investigators

  • Principal Investigator: Mandeep Singh, MD, Mayo Clinic

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Mandeep Singh, Principal Investigator, Mayo Clinic
ClinicalTrials.gov Identifier:
NCT05223335
Other Study ID Numbers:
  • 21-011053
First Posted:
Feb 3, 2022
Last Update Posted:
Apr 1, 2022
Last Verified:
Mar 1, 2022
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Mandeep Singh, Principal Investigator, Mayo Clinic
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 1, 2022