Patients Undergoing Percutaneous Coronary Intervention (PCI) Through Optimal Platelet Inhibition

NCT ID: NCT01582217

Last Updated: 2015-12-23

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 318 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2012-03-31
• Study Completion Date: 2014-12-31

Brief Summary

The purpose of this study is to assess the the 1-year rates of ischemic and bleeding complications in patients whose dual antiplatelet therapy regimen post-PCI has been determined with the use of a clinical algorithm that includes both clinical risks and platelet reactivity while on chronic clopidogrel therapy.

Detailed Description

Prospective multicenter registry. Patients already on chronic dual antiplatelet therapy with aspirin and clopidogrel will be assessed for (1) clinical risks factors for future bleeding and ischemic complications, and (2) on-treatment platelet reactivity as measured by the VerifyNow P2Y12 assay (Accumetrics, Inc., San Diego, CA, USA). These will be considered by utilization of a clinical algorithm to determine the dual antiplatelet regimen post-PCI (aspirin in combination with 1. clopidogrel, 2. prasugrel 5mg daily, or 3. prasugrel 10mg daily).

Conditions

Percutaneous Coronary Intervention; Dual Antiplatelet Therapy; Aspirin; Clopidogrel

Keywords

Bleeding; Risk Score; Outcomes; Prasugrel

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

SA + 5mg prasugrel

Prasugrel 5 mg group: Patients with Intermediate or high bleeding risks and PRU ≥ 230 are Prescribed 5mg of prasugrel daily along with aspirin.

No interventions assigned to this group

ASA + 10 mg prasugrel

Prasugrel 10 mg group: Patients with Low bleeding risk and high ischemia risk and PRU ≥ 230 are prescribed 10 mg of prasugrel daily along with aspirin.

No interventions assigned to this group

ASA + 75 mg clopidogrel daily

Clopidogrel 75 mg group (control): PRU ≤ 230; high bleeding risk or high ischemic risk; patients with active malignancy, age \>75; Wt\< 60kg with previous CVA or TA are prescribed 75 mg of clopidogrel daily along with aspirin.

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• The subject has provided informed written.
• The subject must be ≥ 18 years of age (or minimum age as required by local regulations) at the time of enrollment.
• Patient is established on chronic clopidogrel therapy when he/she returns for PCI, and the components of DAPT are determined by the clinical decision algorithm as local standard of care.
• The subject is willing and able to cooperate with the study procedures and required follow-ups.

Exclusion Criteria

• Patients with cardiogenic shock will be excluded.
• The subject is participating in an investigational device or drug study. Subject must have completed the follow up phase of any previous study at least 30 days prior to enrolment in this study.
• Pregnant women.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Daiichi Sankyo

INDUSTRY

Sponsor Role: collaborator

Accumetrics, Inc.

INDUSTRY

Sponsor Role: collaborator

Icahn School of Medicine at Mount Sinai

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

George Dangas, MD

Role: PRINCIPAL_INVESTIGATOR

Icahn School of Medicine at Mount Sinai

Locations

Mount Sinai Medical Center

New York, New York, United States

Countries

United States

Other Identifiers

FWA # 00005656 and 00005651

Identifier Type: -

Identifier Source: secondary_id

GCO 12-0028

Identifier Type: -

Identifier Source: org_study_id