Ticagrelor monotherapy after stenting

Phase 1

• Conditions: Antiplatelet therapy in patients who undergo coronary artery stenting due to coronary artery disease (CAD) or acute coronary syndrome (ACS).The present study will examine whether ticagrelor, as monotherapy is safe after coronary stenting due to stable CAD and ACS.; MedDRA version: 22.1Level: LLTClassification code 10048560Term: Coronary artery disease aggravatedSystem Organ Class: 100000004849; MedDRA version: 20.0Level: LLTClassification code 10071111Term: Non ST segment elevation acute coronary syndromeSystem Organ Class: 100000004849; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2021-000823-11-SE
• Lead Sponsor: Sahlgrenska University Hospital Gothenburg

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2021-05-17
• Last Update Posted: 18 June 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

1.Men or women at least 18 years old.
2.Pre- or intra-procedure treatment with ticagrelor.
3.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.
4.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)
5.Subject has signed and dated the informed consent form.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 100
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 100

Exclusion Criteria

1.Planned PCI or any planned surgical intervention within the next 6 months.
2.Any indication for chronic anticoagulant therapy
3.Positive COVID-19 antigen or PCR test regardless of symtoms
4.History of definite stent thrombosis
5.Left main coronary artery stenting.
6.Stent thrombosis/restenosis as a culprit lesion.
7.Visible thrombus on angiography after PCI
8.Usage of glycoprotein IIb/IIIa inhibitors
9.Any bifurcation lesion with stenting of both branches.
10.Any treated lesion within an arterial or venous graft.
11.Any additional lesion(s) that need(s) a staged revascularization.
12.Known ejection fraction < 30%.
13.Known severe renal insufficiency (eGFR <30 ml/min/1.72 m2).
14.Any life-threatening conditions or medical comorbidity resulting in life expectancy < 12 months.
15.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).
16.Patients who medicate with a potent CYP3A4 inhibitor (e.g. ketoconazole, clarithromycin, nefazodone, ritonavir and atazanavir)
17.Pregnancy or woman of childbearing potential who is not sterilized or using a medically accepted form of contraception.
18.Expected inability (by the investigator) to comply with the protocol
19. Subjects incapable to giving consent personally

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: A pilot study planned to evaluate initial safety of ticagrelor monotherapy after coronary stenting due to acute myocardial infarction.;Secondary Objective: Not applicable;Primary end point(s): The composite of cardiac death, spontaneous myocardial infarction or definite or probable stent thrombosis within 3 months.;Timepoint(s) of evaluation of this end point: Within 3 months study start i.e. after the Percutaneous Coronary Intervention (PCI)

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Time to the following outcomes at 3- and 12 months (unless specified):<br>-Bleeding Academic Research Consortium (BARC) types 3 or 5 bleeding (time-to-event)<br>-Definite or probable stent thrombosis or spontaneous target vessel myocardial infarction (time-to-event)<br>-Any spontaneous myocardial infarction (time-to-event)<br>-All-cause mortality (time-to-event)<br>-The composite of cardiac death, spontaneous target vessel myocardial infarction or definite or probable stent thrombosis within 12 months.<br>-Platelet reactivity as assessed by the ADP-test (multiplate), at 24 hours and 3 months.<br>;Timepoint(s) of evaluation of this end point: At 3- and 12 months (unless specified)