Individualized anti-platelet therapy in patients with stable coronary artery disease undergoing stenting

Overview

Sponsor-declared trial summary

Key facts

Sponsor

St Antonius Hospital

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Cardiovascular Diseases [C14]

Trial duration

11 Jan 2024 → 25 Feb 2026

Decision date (initial)

2023-06-12

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Funding sources

St. Antonius Onderzoeksfonds · Genedrive

External identifiers

EU CT number

2023-504078-39-01

WHO UTN

U1111-1289-5853

ClinicalTrials.gov

NCT05773989

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Pharmacodynamic, Pharmacogenetic, Therapy

The aim of this study is to assess if a CYP2C19 genotype guided P2Y12-inhibitor monotherapy improves P2Y12-receptor mediated platelet inhibition by measuring platelet reactivity units using the VerifyNow. The primary end point of our study will be levels of platelet reactivity, measured as PRU using the VerifyNow system, of CYP2C19 genotype guided P2Y12-inhibitor monotherapy versus standard DAPT at 30 days after randomization.

Secondary objectives 6

1. To evaluate the pharmacodynamic effects of ticagrelor/prasugrel or clopidogrel monotherapy versus clopidogrel plus aspirin on platelet reactivity and overall platelet-mediated thrombogenicity
2. To evaluate the clinical safety of the intervention compared to the control arm
3. To evaluate the clinical efficacy of the intervention compared to the control arm
4. To evaluate the net clinical benefit of the intervention compared to the control arm
5. To evaluate the treatment adherence in the intervention arm compared to the control arm
6. To assess the comparability of the Genomadix cube to the Genedrive genotype test

Conditions and MedDRA coding

Stable coronary artery disease

Regulatory references

Scientific advice from competent authorities

Medical Research Ethics Committees United

Plan to share IPD

No

IPD plan description

Data may be available on reasonable request.

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 3

1. Patients of 18 years or older
2. Patients with Chronic Coronary Syndrome (CCS) undergoing successful elective percutaneous coronary intervention (PCI)
3. Patients with written informed consent as approved by the ethics committee

Exclusion criteria 12

1. • Contraindication to aspirin
2. • Contraindication to ticagrelor, prasugrel or clopidogrel
3. • Planned cardiac valve surgery
4. • Need for chronic oral anticoagulation
5. • PCI when admitted for ACS
6. • Life expectancy < 1 year
7. • Unable or unwilling to provide informed consent
8. • Pregnancy
9. • History of definite stent thrombosis
10. • Suboptimal result of stenting as defined by the operator, preferably explained according the complex-PCI criteria
11. • Treatment with a strong CYP3A4 inhibitor or inducer
12. • Treatment with a strong CYP2C19 inhibitor or inducer

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Platelet inhibition by measuring platelet reactivity units (PRU) using the VerifyNow at 30 days after randomization

Secondary endpoints 7

1. Platelet reactivity measured using Light Transmission Aggregometry (LTA) and Total Thrombus formation Analysis System (T-TAS) at 30 days after randomization.
2. The bleeding (safety) endpoint is the incidence of minor, moderate or severe bleeding (Bleeding Academic Research Consortium 2, 3 and 5) at 6 months.
3. The efficacy endpoint is major adverse ischemic events (cardiovascular mortality, myocardial infarction, stent thrombosis, stroke, urgent target vessel revascularization) at 6 months
4. Individual components of the primary and secondary end points
5. Net clinical benefit (a composite of all-cause death, MI, stroke and major bleeding defined as BARC type 3 or 5 bleeding) at 6 months
6. The number of patients in whom the antiplatelet drug is prematurely discontinued or switched to another drug
7. The percentage of matching genotype results between the Genomadix and Genedrive test results in the intervention group.

Investigational products

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

Test 3

Comparator 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

St Antonius Hospital

Sponsor organisation

St Antonius Hospital

Address

Koekoekslaan 1

City

Nieuwegein

Postcode

3435 CM

Country

Netherlands

Scientific contact point

Organisation

St Antonius Hospital

Contact name

Wout van den Broek

Public contact point

Organisation

St Antonius Hospital

Contact name

Wout van den Broek

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 8 files

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

Application history

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