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Vitamin-K-Antagonist and direct thrombin inhibitor Dabigatran for thrombus resolution in left ventricular thrombus after acute STEMI: an open label randomized controlled multicenter Phase-II study

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2022-500383-35-00
Enrollment
116
Registered
2024-05-31
Start date
2024-06-04
Completion date
Unknown
Last updated
2024-05-31

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

Conditions

STEMI (ST elevation myocardial infarction), Left ventricular thrombosis

Brief summary

It is defined a binary composite primary endpoint consisting of incomplete thrombus resolution after three months of treatment and the 3-month incidence of a new symptomatic (clinical ischemic stroke) or asymptomatic (“silent” brain infraction detected by screening MRI) brain infarction.

Detailed description

Prevalence of complete thrombus resolution after 3 months of anticoagulant treatment with dabigatran or phenprocoumon., Cumulative 3-month incidence of symptomatic or asymptomatic brain infarction., Cumulative 12-month incidence of symptomatic or asymptomatic brain infarction., Cumulative incidence of bleeding events using the BARC 2,3,5 bleeding criteria during active study (3 months) and 1 year follow up .

Interventions

DRUGCLOPIDOGREL
DRUGACETYLSALICYLIC ACID
DRUGMARCOUMAR - Tabletten

Sponsors

Medical University Of Graz
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
It is defined a binary composite primary endpoint consisting of incomplete thrombus resolution after three months of treatment and the 3-month incidence of a new symptomatic (clinical ischemic stroke) or asymptomatic (“silent” brain infraction detected by screening MRI) brain infarction.

Secondary

MeasureTime frame
Prevalence of complete thrombus resolution after 3 months of anticoagulant treatment with dabigatran or phenprocoumon., Cumulative 3-month incidence of symptomatic or asymptomatic brain infarction., Cumulative 12-month incidence of symptomatic or asymptomatic brain infarction., Cumulative incidence of bleeding events using the BARC 2,3,5 bleeding criteria during active study (3 months) and 1 year follow up .

Countries

Austria

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026