BROKEN-SWEDEHEART- Optimized Pharmacological Treatment for Broken Heart (Takotsubo) Syndrome. A Multinational, Multicentre, Registry-based, Open-label, Randomized Controlled Trial.

NCT04666454 Phase 4 RECRUITING

The aim of this study is to document an optimized pharmacologic treatment for patients with Takotsubo Syndrome. There is currently no published documentation in a large number of patients. The study is a Randomized Registry Clinical Trial and in total 1000 patients registered in SWEDEHEART will be included.

Details

Lead sponsor	Vastra Gotaland Region
Phase	Phase 4
Status	RECRUITING
Enrolment	1000
Start date	2020-12-14
Completion	2028-12

Conditions

• Takotsubo Syndrome

Interventions

• Adenosine
• Dipyridamole 200 mg
• Apixaban 5 mg Oral Tablet
• Care as recommended by the Taskforce on Takotsubo Syndrome of the Heart Failure Association of the European Society of Cardiology for takotsubo syndrome

Primary outcomes

• Randomization 1: First co-primary endpoint: Wall motion score index (defined as the semi-quantitative score according to the American Society of Echocardiography) — 48-96 hours
• Randomization 1: Second co-primary endpoint: The occurrence of the composite of death, cardiac arrest, or the need for cardiac mechanical assist device, or re-hospitalization for heart failure or ejection fraction <50% — up until day 30 day respectively at 48-96 hours
• Randomization 2: The occurrence of any thromboembolic event (defined as ischemic stroke, peripheral arterial embolization or myocardial infarction) or death, or the presence of a cardiac thrombus, as assessed by echocardiography — up until day 30 respectively 48-96 hours

Countries

Denmark, Norway, Sweden