COATS (genetic Clopidogrel response testing to finetune the antithrombotic regimen in (D)OAC Treated patients undergoing PCI) Study

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01], Diseases [C] - Cardiovascular Diseases [C14]

Decision date (initial)

2024-09-13

Transition trial

Yes

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

External identifiers

EU CT number

2024-512350-17-01

EudraCT number

2022-001093-55

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Therapy

The aim of this study is to evaluate the feasibility and safety of CYP2C19-genotype-guided p2y12 inhibitor selection in patients who are indicated for (D)OAC and require PCI. Both safety and efficacy outcomes will be captured.

Secondary objectives 3

1. Safety evaluation in study subgroups
2. Efficacy evaluation in study subgroups
3. Improvement in quality of life (prior- and post-PCI), as assessed by the EQ5D5L questionnaire

Conditions and MedDRA coding

Patients with coronary artery disease and an indication for PCI

Regulatory references

Plan to share IPD

No

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 4

1. Patients ≥ 18 years of age
2. Patients indicated for indefinite (D)OAC
3. Patients undergoing successful PCI for stable or unstable (ACS) coronary artery disease
4. Patients with written informed consent as approved by the ethics committee

Exclusion criteria 10

1. Contraindication to aspirin
2. Contraindication to ticagrelor or clopidogrel
3. Planned cardiac surgery
4. Life expectancy < 1 year
5. Suboptimal result of stenting as defined by the operator
6. Any other condition putting patient at excessive risk for bleeding with ticagrelor
7. Use of gp2b3a inhibitor
8. Need for triple antithrombotic therapy including aspirin per treating physician
9. Treatment with a strong CYP3A4 inhibitor or inducer
10. History of definite stent thrombosis

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 2

1. Primary safety endpoint: Major and CRNM bleeding at 12 months, compared to an objective performance goal (OPG) derived from a meta-analysis of five contemporary (D)OAC + PCI studies, estimated at 14.1%.
2. Primary efficacy endpoint: composite of all-cause mortality, myocardial infarction, stroke and stent thrombosis at 12 months, compared to an OPG of 10.1% for (D)OAC + P2Y12 treated patients.

Secondary endpoints 3

1. Safety evaluation in study subgroups: major and CRNM bleeding at 12 months, compared between the 4 study groups (ACS/ticagrelor vs ACS/clopidogrel vs elective/ticagrelor vs elective/clopidogrel).
2. Efficacy evaluation in study subgroups: composite of all-cause mortality, myocardial infarction, stroke and stent thrombosis at 12 months, compared between the 4 study groups (ACS/ticagrelor vs ACS/clopidogrel vs elective/ticagrelor vs elective/clopidogrel).
3. EQ5D5L questionnaire: a descriptive survey that produces a 5-digit health state profile that represents a level of reported problems for five dimensions of health, to make comparisons between aforementioned patient groups.

Investigational products

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

Test 1

Comparator 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)

Sponsor organisation

Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)

Address

Dr. Molewaterplein 40

City

Rotterdam

Postcode

3015 GD

Country

Netherlands

Scientific contact point

Organisation

Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)

Contact name

Jeroen Wilschut

Public contact point

Organisation

Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)

Contact name

Jeroen Wilschut

Locations

1 EU/EEA country · 2 investigational sites

By country

Investigational sites

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