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Body Weight Adjusted Clopidogrel Treatment in Patients With CORonary Artery Disease

NCT05657041 · Status: UNKNOWN · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2023-06-02

No results posted yet for this study

Summary

Extreme body weights (BW) or body mass index (BMI) affect the pharmacokinetics of antithrombotic drugs and consequently may affect cardiovascular risk during treatment. The goal of this clinical trial is to establish if clopidogrel treatment can be optimized in patients with a low or high BW compared to patients with a normal BW by adjusting the dosage of clopidogrel and evaluating platelet reactivity.

Participants are stratified into three groups based on their BW (Low BW: BW \<60kg; normal BW: 60-100kg; High BW: \>100 kg)

Clopidogrel dosage will then be adjusted to the BW, as follows:

* Low BW: \>10 days clopidogrel 50mg 1dd1, followed by \>10 days clopidogrel 25mg 1dd1.
* Normal BW: Clopidogrel 75mg 1dd1.
* High BW: \>10 days clopidogrel 150mg 1dd1 followed by \>10 days prasugrel 10mg 1dd1.

The primary endpoint of the study is P2Y12 Reaction Units (PRU) and platelet inhibition measured using the VerifyNow measured before starting new treatment regimen (at the end of 10 days of treatment).

Conditions

Interventions

DRUG

Clopidogrel

Body weight adjusted clopidogrel dosing

Sponsors & Collaborators

  • St. Antonius hospital Onderzoeksfonds

    collaborator UNKNOWN

  • Ace pharmaceuticals

    collaborator UNKNOWN

  • Allgen pharmaceuticals

    collaborator UNKNOWN

  • St. Antonius Hospital

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-04-26
Primary Completion
2024-08-01
Completion
2024-11-01

Countries

  • Netherlands

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05657041 on ClinicalTrials.gov