Genotyping Guided Individualized Treatment of Clopidogrel and Ticagrelor in ACS

NCT02048228 | Unknown Phase 2 DMC

• 1 other identifier: NCT01417884
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

Clopidogrel, in addition to aspirin, is the cornerstone of therapy in patients suffering from Acute coronary syndrome. However, the platelet inhibitory response to clopidogrel varies substantially among individuals. Several loss-of-function polymorphisms have been identified that may influence clinical outcome in patients presenting with acute coronary syndromes (ACS) who are treated with clopidogrel. However their contribution to high on-treatment platelet reactivity (HPR) in clopidogrel treated Chinese patients is less known. As far as we know, ticagrelor is not dependent on gene-based metabolic activation and demonstrated greater clinical efficacy than clopidogrel in a recent secondary prevention trial. we will conduct an interventional study to compare the antiplatelet efficiency between clopidogrel and ticagrelor by the guidance of CYP450 2C19\*2 (CYP2C19\*2) , using Taqman genotyping method.

Conditions

CLOPIDOGREL, POOR METABOLISM of (Disorder)

Keywords

Clopidogrel,; Pharmacogenetics,; Platelet reactivity,; CYP2C19,; point-of-care

Outcome Measures

Primary Outcomes (1)

• Clopidogrel response status as measured by the LTA assay in CYP2C19*2 carriers.

  The primary endpoint is the proportion of CYP2C19\*2 carriers with a platelet aggregation more than 59% after 5 days of antiplatelet therapy.The definition of high on-treatment platelet reactivity is derived from previous studies that had identified platelet aggregation more than 59% as optimum cutoff values for prediction of increased risk of major adverse cardiovascular events in Chinese patients.

  Day 5 of enrollment

Study Arms (2)

genotyping guided therapy

EXPERIMENTAL

Patients randomized to the genotyping guided therapy arm will have their CYP2C19\*2 carrier status determined at the time before antiplatelet therapy with subsequent alteration in antiplatelet therapy for \*2 carriers.CYP2C19\*2 carriers will be given 90 mg ticagrelor twice daily, and non-carriers will be given 75 mg clopidogrel daily.

Drug: genotyping guided therapy Ticagrelor, Clopidogrel

Standard Therapy

ACTIVE COMPARATOR

Patients randomized to the Standard Therapy arm will not undergo genotyping. All patients will be administrated with clopidogrel 75 mg daily for 5 consecutive days.

Drug: standard therapy clopidogrel

Interventions

genotyping guided therapy Ticagrelor, Clopidogrel DRUG

CYP2C19\*2 carriers will be given 90 mg ticagrelor twice daily, and non-carriers and patients in the standard treatment group will be given 75 mg clopidogrel daily.

Also known as: Ticagrelor, Clopidogrel

genotyping guided therapy

standard therapy clopidogrel DRUG

All patients will be administrated with clopidogrel 75 mg daily for 5 consecutive days.

Also known as: clopidogrel

Standard Therapy

Eligibility Criteria

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

You may qualify if:

• The diagnosis of ACS including unstable angina (UA),non-ST elevation myocardial infarction(NSTEMI),and ST-elevation MI (STEMI) is according to the American Heart Association/American College of Cardiology (AHA/ACC) criteria

You may not qualify if:

• known contraindication to dual anti-platelet therapy, history of chronic inflammatory disease, steroidal and non-steroidal anti-inflammatory drugs use, previous administration of antiplatelet drugs within 1 month before coronary artery angiography, illicit drug abuse, significant bleeding, cerebrovascular event within 3months, and/or major surgery within 4 weeks.

Sponsors & Collaborators

• Chinese PLA General Hospital: lead

Study Sites (1)

General Hospital of Chinese People's Liberation Army

Beijing, 100853, China

Location

MeSH Terms

Interventions

Clopidogrel; Ticagrelor

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; Adenosine; Purine Nucleosides; Purines; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleosides

Study Officials

• Tong Yin, MD, PhD

  Institute of Geriatric Cardiology, General Hospital of Chinese People's Liberation

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tong Yin, MD, PhD

CONTACT

+86-13693693085; yintong2000@yahoo.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: January 27, 2014
• First Posted: January 29, 2014
• Study Start: October 1, 2014
• Primary Completion: March 1, 2016
• Study Completion: August 1, 2016
• Last Updated: April 11, 2014

Record last verified: 2014-04

Locations

CN (1)