PRAsugrel or clopIdogrel In Acute Coronary SyndromE With CYP2C19 GENEtic Variants

NCT01641510 | Completed Phase 3 DMC

• 1 other identifier: PRAISE-GENE
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

The investigators hypothesize that reduced loading dose of prasugrel followed by reduced maintenance dose of prasugrel in acute coronary syndrome patients with CYP2C19 polymorphism undergoing percutaneous coronary intervention might exhibit lower platelet reactivity 24 hours and 30 days later which is associated with major adverse cardiovascular events.

Conditions

Acute Coronary Syndromes

Keywords

reduced-function CYP2C19 allele; high platelet reactivity; clopidogrel; prasugrel

Outcome Measures

Primary Outcomes (1)

• HPR 1 day

  High platelet reactivity unit defined as platelet reactivity of 242u or more using VerifyNow method at 24 hours after PCI

  24 hours after PCI

Secondary Outcomes (5)

• MACE

  30 days

• Bleeding

  30 days

• HPRs

  4 hours after PCI, 30 days after PCI

• HPR by VASP at 24 hours

  24 hours from PCI

• HPR by VASP at 30 days

  30 days from PCI

Study Arms (2)

Prasugrel

EXPERIMENTAL

Loading and maintenance dose of prasugrel

Drug: Prasugrel

Clopidogrel

ACTIVE COMPARATOR

Loading and maintenance dose of clopidogrel

Drug: Clopidogrel

Interventions

Prasugrel DRUG

Loading with prasugrel 30 mg followed by daily administration of prasugrel 5 mg

Also known as: Effient

Prasugrel

Clopidogrel DRUG

Loading with clopidogrel 600 mg followed by daily administration of clopidogrel 75 mg

Also known as: Plavix, Plavitor

Clopidogrel

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Acute coronary syndrome
• Patients planned to undergo percutaneous transluminal coronary angioplasty
• Patients who agreed to the experimental plan which was permitted by IRB

You may not qualify if:

• Low body weight (\< 50kg)
• History of stroke or transient ischemic attack
• History of upper gastrointestinal bleeding in recent 6 months
• Renal dysfunction defined by serum creatinine \> 2.5 mg/dl
• Severe hepatic dysfunction defined by Child-Pugh criteria B or C
• Bleeding tendency
• Anticoagulation treatment including warfarin
• Thrombocytopenia defined by platelet \< 100,000/ml
• Anemia defined by hemoglobin \< 10 g/dl
• Contraindication for antiplatelet treatment or anticoagulation treatment
• History of administer glycoprotein IIb/IIIa inhibitor in recent 24hrs or planned to

Sponsors & Collaborators

• Dong-A University: lead

Study Sites (1)

DongA University Hospital

Busan, South Korea

Location

MeSH Terms

Conditions

Acute Coronary Syndrome

Interventions

Prasugrel Hydrochloride; Clopidogrel

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

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

Study Officials

• Moo Hyun Kim, MD

  Director, Regional Clinical Trial Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD. Director, Regional Clinical Trial Center. Professor, Dept. of Cardiology Dong-A University Hospital

Study Record Dates

• First Submitted: July 2, 2012
• First Posted: July 16, 2012
• Study Start: October 1, 2013
• Primary Completion: October 1, 2018
• Study Completion: February 1, 2019
• Last Updated: February 11, 2019

Record last verified: 2019-02

Locations

KR (1)