Clopidogrel Response and CYP2C19 Genotype in Ischemic Stroke Patients

NCT03385538 | Completed Phase 4 DMC

• 1 other identifier: 2015-003548-38
• Study Type: interventional
• Target: 103
• Locations: 1 country
• Sites: 1

Brief Summary

Personalized therapy as prophylaxis in ischemic stroke patients is not yet an option. From patients with ischemic heart disease, we know that patients with in vitro high on treatment platelet reactivity (HTPR) have an increased risk of stent thrombosis following per-cutaneous coronary intervention. Other studies have shown association of CYP2C19 genotypes with different responses to the anti platelet drug Clopidogrel. We measure HTPR in ischemic stroke patients on increasing doses of clopidogrel and investigate the CYP2C19 genotype for each patient.

Conditions

Ischemic Stroke

Outcome Measures

Primary Outcomes (3)

• Number of patients who has clopidogrel HTPR

  Clopidogrel responder status measured with VerifyNow

  7 days

• Number of patients who are carriers of CYP2C19 loss-of-function alleles

  Genotyping patients for different loss-of-function CYP2C19 alleeles (\*2, \*3)

  1 day

• Number of patients who are carriers of P2Y12-receptor loss-of-function alleles

  genotyping patients for different loss-of-function P2Y12 receptor alleeles

  1 day

Study Arms (1)

Clopidogrel non-responders

EXPERIMENTAL

Increasing doses og Clopidogrel depending on PRU values measured on VerifyNow

Drug: Clopidogrel

Interventions

Clopidogrel DRUG

increasing doses of clopidogrel depending on PRU values (75-300 mg)

Clopidogrel non-responders

Eligibility Criteria

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

You may qualify if:

• Ischemic stroke diagnosis
• treatment with clopidogrel 75 mg/day

You may not qualify if:

• increased risk of bleeding
• treatment with NOAC, vitamin K antagonist or other antiplatelet drug than clopidogrel
• unable to give informed consent

Sponsors & Collaborators

• Zealand University Hospital: lead

Study Sites (1)

Zealand University Hospital, dept of neurology

Roskilde, 4000, Denmark

Location

MeSH Terms

Conditions

Ischemic Stroke

Interventions

Clopidogrel

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

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

Study Officials

• Charlotte Rath, MD

  Zealand University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 21, 2017
• First Posted: December 28, 2017
• Study Start: November 1, 2015
• Primary Completion: July 30, 2017
• Study Completion: July 30, 2017
• Last Updated: December 28, 2017

Record last verified: 2017-12

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)