Optimized pharmacological treatment for broken heart (takotsubo) syndrome

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2020-002708-38-SE

Enrollment

1000

Registered

2020-06-05

Start date

2020-10-26

Completion date

Unknown

Last updated

2024-02-26

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

Conditions

The medical condition is acute heart failure (Takotsubo syndrome)

Interventions

Trade Name: Adenosine Life Medical 5 mg/ml solution for injection/infusion Product Name: Adenosine Life Medical Product Code: C01EB10 Pharmaceutical Form: Solution for injection Trade Name: Dipyrida

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: A clinical diagnosis of Takotsubo syndrome Age above 18 years Written informed consent 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 700 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 300

Exclusion criteria

Exclusion criteria: Any contra indication for treatment with adenosine or dipyridamole Ongoing treatment with dipyridamole Life expectancy of less than one month

Design outcomes

Primary

Measure	Time frame
Secondary Objective: To investigate whether treatment with apixaban reduces the risk of thromboembolic events compared to no treatment with antithrombotic drugs;Primary end point(s): Factorial design including randomization 1 and randomization 2: Randomization 1 First co-primary endpoint: Wall motion score index at 48-96 hours (defined as the semi-quantitative score according to the American Society of Echocardiography). Second primary endpoint: The occurance of the composite of death, cardiac arrest, or the need for cardiac mechanical assist device up until day 30, or ejaction fraction less than 50% at 48-96 hors post-randomization up until day 30, or re-hospitalisation up until day 30. Randomization 2 The occurance of any thromboembolic event (defined as ischemic stroke, peripheral arterial embolization or myocardial infarction) or death within 30 days or the presence of a cardiac thrombus at48-96 hours as assessed by echocardiography 1. The occurance of the composite of death, cardiac arrest (defined as ventricular fibrillation or asystole more than 30 seconds), or need for cardiac mechanical assist device within 30 days, or ejaction fraction lower than 50 % at 72 hours or rehospitalization for heart failure within 30 days 2. The occurance of any thromboembolic event (ischemic stroke, peripheral arterial embolization or myocardial infarction) or death within 30 days, or the presence of a cardiac thrombos at 72 hours, as assessed by echocardiography ;Timepoint(s) of evaluation of this end point: At day 30 and 48-96 hours post randomization;Main Objective: Objective for randomization 1: To investigate whether treatment with adenosine and dipyridamole improves clinical outcomes in Takotsubo Syndrome compared to standard care according to current recommendations from ESC taskforce for Takotsubo Syndrome	—

Measure

Time frame

Secondary Objective: To investigate whether treatment with apixaban reduces the risk of thromboembolic events compared to no treatment with antithrombotic drugs;Primary end point(s): Factorial design including randomization 1 and randomization 2: Randomization 1 First co-primary endpoint: Wall motion score index at 48-96 hours (defined as the semi-quantitative score according to the American Society of Echocardiography). Second primary endpoint: The occurance of the composite of death, cardiac arrest, or the need for cardiac mechanical assist device up until day 30, or ejaction fraction less than 50% at 48-96 hors post-randomization up until day 30, or re-hospitalisation up until day 30. Randomization 2 The occurance of any thromboembolic event (defined as ischemic stroke, peripheral arterial embolization or myocardial infarction) or death within 30 days or the presence of a cardiac thrombus at48-96 hours as assessed by echocardiography 1. The occurance of the composite of death, cardiac arrest (defined as ventricular fibrillation or asystole more than 30 seconds), or need for cardiac mechanical assist device within 30 days, or ejaction fraction lower than 50 % at 72 hours or rehospitalization for heart failure within 30 days 2. The occurance of any thromboembolic event (ischemic stroke, peripheral arterial embolization or myocardial infarction) or death within 30 days, or the presence of a cardiac thrombos at 72 hours, as assessed by echocardiography ;Timepoint(s) of evaluation of this end point: At day 30 and 48-96 hours post randomization;Main Objective: Objective for randomization 1: To investigate whether treatment with adenosine and dipyridamole improves clinical outcomes in Takotsubo Syndrome compared to standard care according to current recommendations from ESC taskforce for Takotsubo Syndrome

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Secondary

Measure	Time frame
Secondary end point(s): Randomization 1 The hierarchial occurance of time to death, time to cardiac assist device, time to cardiac arrest and ejaction fraction lower than 50 % within day 30 and ejaction fraction lower than 50% at 48-96 hours (binary) Other secondary endpoints: 1. Ejaction fraction at 48-96 (continous) 2. Any sustained ventricular tachycardia or fibrillation within 48-96 hours (binary) 3. Any high-grade atrioventricular block or sinus arrest within 48-96 hours (binary) 4. Need for cardiac assist device up until day 30 (binary) 5. Death up until day 30 6. Stroke up until day 30 7. The following outcomes at 6 months and 1-10 years - re-hospitalization for TS - all cause mortality 8. Worsening heart failure (defined as worsening signs or symptoms of heart failure necessitating intensification of intravenous pharmacologic heart failure therapy) Randomization 2 1.Presence of cardiac thrombus at 48-96 hours 2. Thrombolysis in Myocardial infarction (TIMI) bleeding criteria minor of major up until day 30 3. Bleeding Academic Research Consortium (BARC) grade 2-5 up until day 30 4. BARC grade 3-5 up until day 30 5. Any blood transfusion;Timepoint(s) of evaluation of this end point: Up until day 30 48-96 hours (relevant only for "ejaction fraction"	—

Measure

Time frame

Secondary end point(s): Randomization 1 The hierarchial occurance of time to death, time to cardiac assist device, time to cardiac arrest and ejaction fraction lower than 50 % within day 30 and ejaction fraction lower than 50% at 48-96 hours (binary) Other secondary endpoints: 1. Ejaction fraction at 48-96 (continous) 2. Any sustained ventricular tachycardia or fibrillation within 48-96 hours (binary) 3. Any high-grade atrioventricular block or sinus arrest within 48-96 hours (binary) 4. Need for cardiac assist device up until day 30 (binary) 5. Death up until day 30 6. Stroke up until day 30 7. The following outcomes at 6 months and 1-10 years - re-hospitalization for TS - all cause mortality 8. Worsening heart failure (defined as worsening signs or symptoms of heart failure necessitating intensification of intravenous pharmacologic heart failure therapy) Randomization 2 1.Presence of cardiac thrombus at 48-96 hours 2. Thrombolysis in Myocardial infarction (TIMI) bleeding criteria minor of major up until day 30 3. Bleeding Academic Research Consortium (BARC) grade 2-5 up until day 30 4. BARC grade 3-5 up until day 30 5. Any blood transfusion;Timepoint(s) of evaluation of this end point: Up until day 30 48-96 hours (relevant only for "ejaction fraction"

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Countries

Sweden

Contacts

Public ContactChrister Söderström

Gothia Forum

christer.soderstrom@vgregion.se

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026