Clopidogrel Monotherapy in Patients With High Bleeding Risk

NCT05223335 | Completed Phase 4 Results FDA Drug

• 1 other identifier: 21-011053
• Study Type: interventional
• Target: 98
• Locations: 1 country
• Sites: 1

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).

Conditions

Bleeding Complications

Keywords

Antiplatelet medications; Blood thinners; Stent thrombosis; Percutaneous Coronary Intervention

Outcome Measures

Primary Outcomes (1)

• Ischemic Risk Post-PCI in High Bleed Risk Patients With Genotype-guided Single Antiplatelet Therapy

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

  Through study completion, approximately 90 days.

Study Arms (2)

Genotype-Guided Therapy

EXPERIMENTAL

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 loss-of-function (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; Drug: Tricagrelor

Conventional Therapy

ACTIVE COMPARATOR

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 loss-of-function (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

Interventions

Clopidogrel DRUG

75 mg/day

Conventional Therapy

Prasugrel DRUG

60 mg bolus then 10 mg daily

Genotype-Guided Therapy

Tricagrelor DRUG

180 mg bolus then 90 mg twice daily

Genotype-Guided Therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Informed consent in adults
• Successful percutaneous coronary intervention (PCI) \[no non-fatal myocardial infarction (MI)/stroke/repeat target revascularization/bleeding/acute kidney injury\].
• Academic research consortium-high bleeding risk (ARC-HBR) score ≥ 4.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Related Publications (1)

• Ingraham BS, Huxley SB, Lane CM, Gulati R, Lewis BR, Jaffe AS, Bell MR, Lerman A, Pereira NL, Moyer AM, Baudhuin LM, Rihal CS, Singh M. Genotype-Guided P2Y12 Inhibitor Monotherapy Within 7 Days of Percutaneous Coronary Intervention in High Bleeding Risk Patients: The CHAMP Trial - A Pilot Study and Safety Assessment. Mayo Clin Proc. 2025 Jan;100(1):94-108. doi: 10.1016/j.mayocp.2024.05.030. Epub 2024 Nov 26.

  PMID: 39601743 DERIVED

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Interventions

Clopidogrel; Prasugrel Hydrochloride

Intervention Hierarchy (Ancestors)

Ticlopidine; Thienopyridines; Thiophenes; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Piperazines

Results Point of Contact

• Title: Mandeep Singh, M.D.
• Organization: Mayo Clinic

Singh.Mandeep@mayo.edu

507-255-2398

Study Officials

• Mandeep Singh, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 6, 2022
• First Posted: February 3, 2022
• Study Start: March 29, 2022
• Primary Completion: March 16, 2023
• Study Completion: March 16, 2023
• Last Updated: February 21, 2024
• Results First Posted: February 21, 2024

Record last verified: 2024-02

Locations

US (1)