Body Weight Adjusted Clopidogrel Treatment in Patients With CORonary Artery Disease

NCT05657041 | Unknown Phase 2

• 1 other identifier: NL81095.100.22
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 2

Brief 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

Coronary Artery Disease; Platelet Reactivity

Keywords

Antithrombotic Drugs; Pharmacodynamics; Clopidogrel

Outcome Measures

Primary Outcomes (4)

• Platelet reactivity

  Change in P2Y12 Reaction Units (PRU) measured using the VerifyNow

  Baseline and 10 days after dose alteration

• High on-treatment platelet reactivity (HTPR)

  Number of participants with high on-treatment platelet reactivity (HTPR) defined by a PRU \>208

  Baseline

• High on-treatment platelet reactivity (HTPR)

  Number of participants with high on-treatment platelet reactivity (HTPR) defined by a PRU \>208

  10 days

• High on-treatment platelet reactivity (HTPR)

  umber of participants with high on-treatment platelet reactivity (HTPR) defined by a PRU \>208

  20 days

Secondary Outcomes (5)

• Bleeding complications

  30 days

• Myocardial infarction

  30 days

• Stroke

  30 days

• Stent thrombosis

  30 days

• All-cause death

  30 days

Study Arms (3)

Group 1: body weight <60kg

EXPERIMENTAL

Treatment with clopidogrel 50mg once daily for a minimum of 10 days (max. 14 days), followed by a minimum of 10 days treatment with clopidogrel 25mg once daily (max 14 days).

Drug: Clopidogrel

Group 2: body weight 60-100kg

NO INTERVENTION

Treatment with clopidogrel 75mg once daily

Group 3: body weight >100kg

EXPERIMENTAL

Treatment with clopidogrel 150mg once daily for a minimum of 10 days (max. 14 days), followed by a minimum of 10 days treatment with prasugrel 10mg once daily (max 14 days).

Drug: Clopidogrel

Interventions

Clopidogrel DRUG

Body weight adjusted clopidogrel dosing

Also known as: Prasugrel, Body weight adjusted

Group 1: body weight <60kg; Group 3: body weight >100kg

Eligibility Criteria

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

You may qualify if:

• Patients, male or female, ≥18 years of age
• Patients treated for CCS with clopidogrel 75mg QD (aspirin 100mg QD).
• Patients must be treated with clopidogrel 75mg for at least one month
• Patients must give consent by means of a signed informed consent

You may not qualify if:

• Contra-indication for aspirin
• Contra-indication for clopidogrel or prasugrel
• Occurrence of an ischemic event after PCI or ACS (stroke, myocardial infarction, or coronary revascularization)
• Presence of unstable angina complaints.
• Presence of two CYP2C19 Loss-of-function (LOF) alleles (\*2 or \*3)
• Scheduled for cardiac valve surgery
• Indication for chronic oral anticoagulants
• Expected life span of less than one year
• Pregnancy
• Suboptimal stent placement as determined by the cardiologist.
• Patients at increased risk of bleeding with two of the following characteristics: liver cirrhosis with portal hypertension, enhanced bleeding tendency, active malignancy in the past 12 months, thrombocytopenia, major surgery in the past month, spontaneous intracerebral haemorrhage, traumatic intracerebral haemorrhage in the past 12 months, major bleeding requiring hospitalisation or blood transfusion in the past month, ischaemic CVA in the past 5 months.
• Known with established stent thrombosis

Sponsors & Collaborators

• St. Antonius Hospital: lead
• St. Antonius hospital Onderzoeksfonds: collaborator
• Ace pharmaceuticals: collaborator
• Allgen pharmaceuticals: collaborator

Study Sites (2)

StAntoniusH

Nieuwegein, Utrecht, 3435CM, Netherlands

NOT YET RECRUITING

St. Antonius Hospital

Nieuwegein, Netherlands

RECRUITING

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

Clopidogrel; Prasugrel Hydrochloride

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular 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; Piperazines

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. dr.

Model Details: prospective, experimental study

Study Record Dates

• First Submitted: November 18, 2022
• First Posted: December 20, 2022
• Study Start: April 26, 2023
• Primary Completion: August 1, 2024
• Study Completion: November 1, 2024
• Last Updated: June 2, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

NL (2)