BridgeMD
Ticagrelor monotherapy after coronary stenting in patients with acute myocardial infarction - A prospective single-centre, single-arm phase II study
EU CTIS ID: 2024-514224-17-00
What this study is testing
A pilot study planned to evaluate initial safety of ticagrelor monotherapy after coronary stenting due to acute myocardial infarction.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Men or women at least 18 years old.
- Pre- or intra-procedure treatment with ticagrelor.
- Coronary stenting with an everolimus-eluting stent (EES) due to NSTEMI or STEMI, with post-procedure diameter stenosis <50% and post-procedure Thrombolysis In Myocardial Infarcton (TIMI) flow grade 3.
- Subject has not yet received any post-procedure dose of aspirin or any post-procedure dose of a different P2Y12 inhibitor than ticagrelor (loading dose or pre-PCI maintenance dose of aspirin and/or a different P2Y12 inhibitor is allowed).
- Subject has signed and dated the informed consent form.
You likely can't join if
- Planned PCI or any planned surgical intervention within the next 6 months.
- Any treated lesion within an arterial or venous graft.
- Any additional lesion(s) that need(s) a staged revascularization.
- Known ejection fraction <30%.
- Known severe renal insufficiency (eGFR <30 ml/min/1.72 m2).
- Any life-threatening conditions or medical comorbidity resulting in life expectancy < 12 months.
See the full eligibility criteria
- Men or women at least 18 years old.
- Pre- or intra-procedure treatment with ticagrelor.
- Coronary stenting with an everolimus-eluting stent (EES) due to NSTEMI or STEMI, with post-procedure diameter stenosis <50% and post-procedure Thrombolysis In Myocardial Infarcton (TIMI) flow grade 3.
- Subject has not yet received any post-procedure dose of aspirin or any post-procedure dose of a different P2Y12 inhibitor than ticagrelor (loading dose or pre-PCI maintenance dose of aspirin and/or a different P2Y12 inhibitor is allowed).
- Subject has signed and dated the informed consent form.
- Planned PCI or any planned surgical intervention within the next 6 months.
- Any treated lesion within an arterial or venous graft.
- Any additional lesion(s) that need(s) a staged revascularization.
- Known ejection fraction <30%.
- Known severe renal insufficiency (eGFR <30 ml/min/1.72 m2).
- Any life-threatening conditions or medical comorbidity resulting in life expectancy < 12 months.
- Participation in any investigational study that has not yet reached its primary endpoint, and for which monotherapy with ticagrelor may affect the primary outcome (as per the judgement of the investigator).
- Patients who medicate with a potent CYP3A4 inhibitor (e.g. ketoconazole, clarithromycin, nefazodone, ritonavir and atazanavir)
- Pregnancy or woman of childbearing potential who is not sterilized or using a medically accepted form of contraception.
- Expected inability (by the investigator) to comply with the protocol
- Subjects incapable to giving consent personally
- Any indication for chronic anticoagulant therapy.
- Positive COVID-19 antigen or PCR test regardless of symptoms.
- History of definite stent thrombosis.
- Left main coronary artery stenting.
- Stent thrombosis/restenosis as a culprit lesion.
- Visible thrombus on angiography after PCI.
- Usage of glycoprotein IIb/IIIa inhibitors.
- Any bifurcation lesion with stenting of both branches.
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.