The dosage of antithrombotics adjusted to body weight

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Sint Antonius Ziekenhuis Stichting

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Cardiovascular Diseases [C14]

Trial duration

12 Nov 2024 → ongoing

Decision date (initial)

2024-11-12

Transition trial

Yes

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

External identifiers

EU CT number

2024-518890-33-00

EudraCT number

2022-001290-31

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy, Therapy, Dose response

To determine if clopidogrel treatment can be optimized in patients with a low or high body weight/Body Mass Index (BMI) compared to patients with a normal body weight/BMI by adjusting the dosage of clopidogrel and evaluating platelet reactivity measured using the VerifyNow.

Secondary objectives 1

1. To determine if the CYP2C19 genotype has additional effect on the platelet reactivity in the different treatment groups

Conditions and MedDRA coding

Chronic coronary syndrome

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 4

1. Patients, male or female, ≥18 years of age
2. Patients treated for chronic coronary syndrome with clopidogrel 75mg QD (aspirin 100mg QD)
3. Patients must be treated with clopidogrel 75mg for at least one month
4. Patients must give consent by means of a signed informed consent

Exclusion criteria 12

1. Contra-indication for aspirin
2. Contra-indication for clopidogrel or prasugrel
3. Occurrence of an ischemic event after percutaneous coronary intervention or acute coronary syndrome (stroke, myocardial infarction, or coronary revascularization)
4. Presence of unstable angina complaints
5. Presence of two CYP2C19 Loss-of-function (LOF) alleles (*2 or *3)
6. Scheduled for cardiac valve surgery
7. Indication for chronic oral anticoagulants
8. Expected life span of less than one year
9. Pregnancy
10. Suboptimal stent placement as determined by the cardiologist
11. 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 cerebrovascular accident in the past 5 months.
12. Known with established stent thrombosis

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Level of platelet reactivity, measured as Platelet Reaction Unit, as measured by the VerifyNow system

Secondary endpoints 10

1. To determine if the CYP2C19 genotype has additional effect on the platelet reactivity in the different treatment groups.
2. To assess the difference between PRU values in the high bodyweight/BMI group during clopidogrel treatment and prasugrel treatment.
3. To assess possible confounders for HTPR.
4. Mortality (and cause of mortality)
5. Myocardial infarction
6. Stent thrombosis
7. Revascularization
8. Stroke
9. Bleedings
10. To correlate the measured body fat percentages with PRU values.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 2

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Sint Antonius Ziekenhuis Stichting

Sponsor organisation

Sint Antonius Ziekenhuis Stichting

Address

Koekoekslaan 1

City

Nieuwegein

Postcode

3435 CM

Country

Netherlands

Scientific contact point

Organisation

Sint Antonius Ziekenhuis Stichting

Contact name

Qiu Ying van de Pol

Public contact point

Organisation

Sint Antonius Ziekenhuis Stichting

Contact name

Qiu Ying van de Pol

Locations

1 EU/EEA country · 1 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 6 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

1 submissions — initial application plus substantial / non-substantial modifications