2024-512350-17-01Not yet recruitingPhase 4
COATS (genetic Clopidogrel response testing to finetune the antithrombotic regimen in (D)OAC Treated patients undergoing PCI) Study
Source: EU CTIS (euclinicaltrials.eu) · Last updated 13 Sept 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 520 (estimated)
- First submitted
- 2 Sept 2024
- Start date
- 19 Apr 2023
- Lead sponsor
- Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
- Diseases
- Coronary artery disease
- EU CT number
- 2024-512350-17-01
- EudraCT number
- 2022-001093-55
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 520
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study design.
AI-kivonat: who the study is looking for
Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults who need long-term blood thinners and are having a successful stent procedure (PCI) for coronary artery disease.
- Age
- 18 years or older
- Sex
- All sexes can join.
- Disease stage
- Stable or unstable (acute coronary syndrome) coronary artery disease, treated with a successful PCI.
- Earlier treatment
- Must be indicated for indefinite (D)OAC (long-term oral blood thinner). Those who need triple antithrombotic therapy including aspirin, or who take a strong CYP3A4 inhibitor or inducer, cannot join.
Main reasons for not taking part
- Contraindication to aspirin, ticagrelor or clopidogrel
- History of definite stent thrombosis
- Planned cardiac surgery
- Life expectancy under 1 year
- Use of gp2b3a inhibitor
Read by machine on 9 Nov 2026.
Who cannot take part
Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Use of gp2b3a inhibitor
- Need for triple antithrombotic therapy including aspirin per treating physician
- Treatment with a strong CYP3A4 inhibitor or inducer
Other illness
- History of definite stent thrombosis
- Planned cardiac surgery
- Any other condition putting patient at excessive risk for bleeding with ticagrelor
Other
- Contraindication to aspirin
- Contraindication to ticagrelor or clopidogrel
- Life expectancy < 1 year
- Suboptimal result of stenting as defined by the operator
Who the study is looking for
- Patients ≥ 18 years of age
- Patients indicated for indefinite (D)OAC
- Patients undergoing successful PCI for stable or unstable (ACS) coronary artery disease
- Patients with written informed consent as approved by the ethics committee
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC) | Rotterdam | Netherlands | Not yet recruiting |
| Maasstad Ziekenhuis Stichting | Rotterdam | Netherlands | Not yet recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.