The safety of ticagrelor monotherapy after primary percutaneous coronary intervention for ST-elevation myocardial infarction and the effect on intramyocardial haemorrhage

The safety of ticagrelor monotherapy after primary percutaneous coronary intervention for ST-elevation myocardial infarction and the effect on intramyocardial haemorrhage - STOP IMH

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON56396

Enrollment

200

Registered

2023-01-10

Start date

2023-07-06

Completion date

Unknown

Last updated

2024-10-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

ST-elevation myocardial infarction

Interventions

Patients in the treatment arm will continue with ticagrelor monotherapy after PPCI. The control arm will receive ticagrelor based DAPT for 12 months.

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Patients aged 18 years or older are eligible for inclusion if all of the following criteria are met: - Clinical and electrocardiographical diagnosis of ST-elevation myocardial infarction (STEMI) - Successful percutaneous coronary intervention (PCI) of the infarct-related vessel with a modern drug eluting stent (DES)

Exclusion criteria

Exclusion criteria: - Known allergy or contraindication for aspirin, ticagrelor or prasugrel. - Previous PCI or MI less than 12 months ago - Previous cardiac surgery - Participation in another clinical study with an investigational product - Pregnancy and breast feeding - Concurrent use of oral anticoagulants (OAC) - The periprocedural use of GPIIb/IIIa inhibitors - Planned surgical intervention within 12 months of PCI - Creatinine clearance

Design outcomes

Secondary

Measure	Time frame
Secondary endpoints: • IMH and infarct size measured by CMR • Bleeding complications BARC >= 2 • Platelet reactivity in ticagrelor monotherapy and tcagrelor + ASA • All-cause mortality	—

Primary

Measure	Time frame
Primary endpoints: Composite of major adverse cardiac and cerebral events (MACCE), consisting of: - Myocardial infarction - Stent thrombosis - Ischemic stroke - Cardiovascular mortality/All-cause mortality	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)