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A phase II, multicenter, 1:1 randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy of bolus application of Cyclosporine A (CsA) or Placebo in patients with Takotsubo syndrome. (Cyclosporine In Takotsubo syndrome (CIT))
EU CTIS ID: 2024-511037-35-00
What this study is testing
The primary objective of this translational early clinical trial is to investigate whether TTS patients treated with cyclosporine A (CsA) compared to placebo in addition to standard of care reveal reduced myocardial damage. In order to accurately determine myocardial damage centrally measured high-sensitive Troponin T (TnT) AUC has been chosen as the primary endpoint, and after careful consideration of other options. Initial troponin levels have been shown to predict outcome in patients1, 38. However, assay heterogeneity between institutions has kept this parameter from e. g. entering the Mayo Clinic Risk Score. A centrally measured TnT AUC is more reliable regarding quantification of myocardial injury when compared to single TnT values from different laboratories39-41. Besides yielding a larger effect size in our in vivo studies, TnT as a primary endpoint features higher sensitivity compared e.g. to imaging-based EF measurements. Therefore, the primary endpoint of this study is the high-sensitive troponin T AUC over 72h (baseline, 3h, 12h, 24h, 36h, 48h, 60h, 72h) between placebo vs. CsA.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Patients aged over 18
- Enrollment and first IMP administration within 24 hours after cardiac catheterization
- Regional Wall Motion Abnormality (WMA) consistent with TTS in angiography or echocardiography
- InterTAK prognostic score ≥ 9 or GEIST Score ≥ 9
- Written informed consent
You likely can't join if
- Acute coronary syndrome (ACS) with significant coronary stenosis potentially associated with wall motion abnormalities (WMA) or percutaneous coronary intervention (PCI)
- History of chronic renal insufficiency (either creatinin clearance <30 ml/min/1.73m² or current medical care for severe renal insufficiency)
- History of liver insufficiency
- Uncontrolled hypertension at the time of screening for study inclusion (systolic blood pressure >180mmHg and/or diastolic blood pressure >110mmHg)
- Current medication with any compound containing Hypericum perforatum (St. John’s worth) or Stiripentol or Aliskiren or Bosentan or Rosuvastatine (Rosuvastatine > 5mg within 24h before IMP administration)
- Female patients currently pregnant or women of childbearing age without negative pregnancy test or without effective contraception
See the full eligibility criteria
- Patients aged over 18
- Enrollment and first IMP administration within 24 hours after cardiac catheterization
- Regional Wall Motion Abnormality (WMA) consistent with TTS in angiography or echocardiography
- InterTAK prognostic score ≥ 9 or GEIST Score ≥ 9
- Written informed consent
- Acute coronary syndrome (ACS) with significant coronary stenosis potentially associated with wall motion abnormalities (WMA) or percutaneous coronary intervention (PCI)
- History of chronic renal insufficiency (either creatinin clearance <30 ml/min/1.73m² or current medical care for severe renal insufficiency)
- History of liver insufficiency
- Uncontrolled hypertension at the time of screening for study inclusion (systolic blood pressure >180mmHg and/or diastolic blood pressure >110mmHg)
- Current medication with any compound containing Hypericum perforatum (St. John’s worth) or Stiripentol or Aliskiren or Bosentan or Rosuvastatine (Rosuvastatine > 5mg within 24h before IMP administration)
- Female patients currently pregnant or women of childbearing age without negative pregnancy test or without effective contraception
- Any disorder associated with immunological dysfunction ≤6 months prior to presentation (autoimmune disease, known positive serology for HIV or hepatitis)
- Immunosuppressive, chemotherapeutical, or antibody treatment
- Participation in other clinical trials except for non-interventional trials
- Neither male nor female at birth
- Infection (defined as concomitant infection with a positive blood culture at the time of study inclusion)
- History of hypersensitivity to cyclosporine
- History of hypersensitivity to egg, peanut or soybean proteins
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.