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

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Medical University Of Graz

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Cardiovascular Diseases [C14]

Trial duration

4 Jun 2024 → 31 Mar 2026

Decision date (initial)

2024-05-31

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Funding sources

Boehringer Ingelheim RCV GmbH & Co KG

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Therapy, Efficacy

To estimate the proportion of patients experiencing thrombus resolution and/or symptomatic or asymptomatic brain infarction after 3 months of anticoagulant treatment with dabigatran or phenoprocoumon in patients with left ventricular thrombus after STEMI (ST-elevation myocardial infarction).

Conditions and MedDRA coding

STEMI (ST elevation myocardial infarction)

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 5

1. Patients diagnosed with STEMI undergoing PCI (percutaeous coronary intervention) and having the LAD (left anterior descending artery) as the culprit vessel
2. Clinical risk score for LV-Thrombus >2 points
3. Age 18 years or older
4. Informed consent has to be given in written form
5. eGFR > 30 ml/min/1.73m2

Exclusion criteria 16

1. Any other form of myocardial infarction (NSTEMI) than STEMI
2. Active bleeding or any prior bleeding episode in the last seven days other than intracranial bleeding
3. Intracranial bleeding in the last 6 months
4. Known allergy to thrombin inhibitor dabigatran
5. Haemodynamic instability as defined by intravenous administration of catecholamine, calciumsensitizers or phosphodiesterase inhibitors
6. Pregnancy or Breastfeeding
7. Preexisting oral anticoagulant therapy (VKA or NOAC)
8. eGFR < 30ml/min/1.73m2
9. Parallel, ongoing participation in another pharmacological trial
10. Known intracardiac thrombus (including cardiac ear thrombi)
11. Cirrhosis of the liver (Child A-C)
12. Any contraindication to study drugs or auxiliary drugs
13. Any contraindication for an cardiac MRI (e.g. metal implants or non-certified pacemaker systems)
14. Persons unable to give consent or cannot understand the purpose of the study (dementia, etc.), or should be excluded by investigator's decision
15. Persons who cannot take the study measures / tablets or have a questionable compliance
16. Persons with limited life expectancy (< 3 months)

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. 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 endpoints 4

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

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 2

Comparator 1

Auxiliary 2

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Medical University Of Graz

Sponsor organisation

Medical University Of Graz

Address

Auenbruggerplatz 2

City

Graz

Postcode

8036

Country

Austria

Scientific contact point

Organisation

Medical University Of Graz

Contact name

Coordination Center for Clinical Trials

Public contact point

Organisation

Medical University Of Graz

Contact name

Coordination Center for Clinical Trials

Locations

1 EU/EEA country · 5 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Application history

1 submissions — initial application plus substantial / non-substantial modifications