Cardiovascular clinical trial failures

Phase II Pulmonary Arterial Hypertension trial by Keros Therapeutics, Inc.. Stop reason: SAFETY.

The study was voluntarily terminated early, following a safety review and observation of pericardial effusions.

Phase I Diastolic Dysfunction trial by Texas Tech University Health Sciences Center. Stop reason: OTHER/UNKNOWN.

Had issue enrolling subjects.

Unknown Heart Failure (for Example, Fluid Overload) trial by Nuwellis, Inc.. Stop reason: OPERATIONAL.

The study was stopped early due to slow enrollment and was a business decision. This decision was not based on any efficacy or safety concerns.

Phase II Myocardial Infarction trial by Boehringer Ingelheim. Stop reason: OPERATIONAL.

Sponsor decision

Phase III Pre-Eclampsia trial by The University of Texas Medical Branch, Galveston. Stop reason: EFFICACY/FUTILITY.

Futility of the study

Phase II Myocardial Infarction trial by Alexion Pharmaceuticals, Inc.. Stop reason: OPERATIONAL.

Administrative reasons.

Phase IV Valvular Heart Surgery trial by SHI Jia. Stop reason: OTHER/UNKNOWN.

At a meeting on February 17, 2025, the Data and Safety Monitoring Board recommended early termination because the predefined efficacy boundary was crossed.

Phase IV Primary Pulmonary Arterial Hypertension trial by Heidelberg University. Stop reason: OPERATIONAL.

Strategic re-prioritization by the IMP supplier. Decision not safety-related

Phase I Perinatal Arterial Ischemic Stroke trial by James Baumgartner, MD. Stop reason: SAFETY.

The FDA required a clinical hold for the IND which remained until it was determined that the study would be closed.

Phase II Myocardial Infarction, Acute trial by University Hospital, Montpellier. Stop reason: OTHER/UNKNOWN.

Inclusion period completed

Phase III Thrombotic Microangiopathies trial by University Hospital, Rouen. Stop reason: OTHER/UNKNOWN.

Change in the molecule

Phase III Pulmonary Arterial Hypertension trial by Acceleron Pharma, Inc., a wholly-owned subsidiary of Merck & Co., Inc., Rahway, NJ USA. Stop reason: OTHER/UNKNOWN.

Study was stopped early due to loss of clinical equipoise based on robust evidence of clinical benefit of sotatercept demonstrated in previous studies.

Phase II Primary Myelofibrosis trial by University of Utah. Stop reason: OPERATIONAL.

PI and Sponsor decision. Accrual was low and there was sufficient data to detect a response.

Unknown Heart Failure With Reduced Ejection Fraction (HFrEF) trial by Ancora Heart, Inc.. Stop reason: OPERATIONAL.

Recruitment on hold pending modifications to the clinical investigation plan

Phase II Cardiomyopathy, Hypertrophic trial by Bristol-Myers Squibb. Stop reason: OTHER/UNKNOWN.

Business objectives have changed

Phase I Coronary Artery Disease trial by Vanderbilt University. Stop reason: OPERATIONAL.

poor enrollment

Phase II Accelerated Phase Myeloproliferative Neoplasm trial by National Cancer Institute (NCI). Stop reason: OTHER/UNKNOWN.

Other - Protocol amendment to add additional dose levels

Phase II Acute Coronary Syndrome trial by Shaanxi Micot Pharmaceutical Technology Co., Ltd.. Stop reason: OTHER/UNKNOWN.

The study was decided to be terminated due to commercial considerations,（not the safety issues of the product）.

Phase III Pulmonary Hypertension trial by United Therapeutics. Stop reason: OPERATIONAL.

Sponsor's decision

Phase II CPVT1 trial by Cardurion Pharmaceuticals, Inc.. Stop reason: OPERATIONAL.

The early termination of the clinical trial is due to an internal administrative and business decision, the study is not being terminated for safety reasons.

Phase IV ST Elevation Myocardial Infarction (STEMI) trial by Henan Institute of Cardiovascular Epidemiology. Stop reason: OPERATIONAL.

Slow patient enrollment and lack of financial support

Phase II Acute Ischemic Stroke trial by Tanabe Pharma Corporation. Stop reason: OTHER/UNKNOWN.

Business objectives have changed.

Phase I Postoperative Chylothorax trial by June Wu. Stop reason: OPERATIONAL.

Administrative changes

Phase II HFrEF - Heart Failure With Reduced Ejection Fraction trial by Salubris Biotherapeutics Inc. Stop reason: OPERATIONAL.

Sponsor decision

Unknown Cardiovascular Diseases trial by University Hospital, Linkoeping. Stop reason: OTHER/UNKNOWN.

The study was terminated prematurely due to insufficient operational resources to continue trial conduct and completion. The decision was unrelated to safety concerns or study outcomes.

Phase I Left Ventricular Dysfunction trial by Shanghai Life Science & Technology. Stop reason: OPERATIONAL.

budget control

Phase IV Coronary Artery Disease trial by Ottawa Heart Institute Research Corporation. Stop reason: OTHER/UNKNOWN.

Testing supplies unavailable.

Phase IV Postpartum Pregnancy-Induced Hypertension trial by Columbia University. Stop reason: OPERATIONAL.

Principal investigator left the institution

Phase II Pulmonary Hypertension trial by Bastiaan Driehuys. Stop reason: OPERATIONAL.

Funding Ended.

Phase II Coronary Microvascular Dysfunction trial by Lisata Therapeutics, Inc.. Stop reason: OPERATIONAL.

Sponsor decision

Phase IV Ventricular Tachycardia trial by Ottawa Heart Institute Research Corporation. Stop reason: OPERATIONAL.

Low recruitment. Pilot trial.

Phase III Hypertension trial by Ablative Solutions, Inc.. Stop reason: SAFETY.

Study enrollment and treatment are temporarily suspended due to an FDA clinical hold. The sponsor is actively addressing the FDA's requests.

Phase II Intracerebral Haemorrhage, Intraventricular trial by University of Maryland, Baltimore. Stop reason: OPERATIONAL.

Loss of Financial Sponsor

Phase IV Heart Failure trial by Sarfez Pharmaceuticals, Inc.. Stop reason: OPERATIONAL.

Recruitment issues

Phase IV Myocardial Infarction trial by Seoul National University Hospital. Stop reason: OTHER/UNKNOWN.

The study was terminated early due to a shortage of research and analytical personnel, which prevented the completion of the study as planned

Phase II Heart Failure trial by Sarfez Pharmaceuticals, Inc.. Stop reason: OPERATIONAL.

Recruitment issues.

Phase IV Variant Angina trial by Seoul National University Hospital. Stop reason: OPERATIONAL.

The study was terminated early due to slow recruitment and the Principal Investigator's retirement.

Phase II COVID-19 trial by Cardiol Therapeutics Inc.. Stop reason: OPERATIONAL.

The changing nature of COVID-19 including a more vaccinated population, increasing natural population immunity, milder variants and other related factors has meant that it is no longer realistic to recruit the patients in a reasonable time frame.

Phase III Venous Thromboembolism trial by Anthos Therapeutics, Inc.. Stop reason: OPERATIONAL.

Sponsor Decision

Phase II Heart Failure trial by Otsuka Pharmaceutical Development & Commercialization, Inc.. Stop reason: OTHER/UNKNOWN.

No sites were initiated, no sites were activated, no patients were enrolled in this study.

Phase I Stroke, Ischemic trial by Northwell Health. Stop reason: OTHER/UNKNOWN.

it was very difficult to enroll in this acute population

Phase II Non-Ischemic Heart Failure trial by Cell to Cure ApS. Stop reason: OTHER/UNKNOWN.

Due to changes in company structure and investment the trial will not be initiated.

Phase III Chronic Kidney Diseases trial by University of Southampton. Stop reason: OPERATIONAL.

Planned recruitment total was not achievable within the funded timeframe

Phase II Pulmonary Embolism trial by University of California, Los Angeles. Stop reason: OTHER/UNKNOWN.

no sponsor support

Phase IV Coronary Artery Disease trial by Instituto Nacional de Cardiologia Ignacio Chavez. Stop reason: OTHER/UNKNOWN.

The sample was not completed.

Phase II Heart Failure trial by Pfizer. Stop reason: SAFETY.

Following a prespecified interim analysis, and in consultation with the independent Data Monitoring Committee, the Sponsor terminated the study

Phase I Pulmonary Embolism trial by Peter Caravan. Stop reason: OPERATIONAL.

The study did not reach its enrollment target due to a relatively narrow time window for imaging after the contrast CT imaging confirmed PE and limitations in the availability of the tracer and the PET scanner.

Phase IV Positive Helicobacter Pylori Serology trial by Assistance Publique - Hôpitaux de Paris. Stop reason: OTHER/UNKNOWN.

no inclusion

Phase II Fetal and Neonatal Alloimmune Thrombocytopenia trial by Rallybio. Stop reason: OTHER/UNKNOWN.

This study was terminated early by the sponsor due to insufficient drug exposure to achieve the intended therapeutic effect.

Phase II Acute Ischemic Stroke trial by State University of New York at Buffalo. Stop reason: OPERATIONAL.

Study never started, no participants enrolled due to lack of funding

Phase II ST Elevation Myocardial Infarction trial by University of Alberta. Stop reason: OTHER/UNKNOWN.

Unlikely to demonstrate the intended benefit within the planned study design and statistical framework.

Phase III Venous Thromboembolism trial by Anthos Therapeutics, Inc.. Stop reason: OPERATIONAL.

Sponsor decision

Phase II Transthyretin Amyloid Cardiopathy trial by Brigham and Women's Hospital. Stop reason: REGULATORY.

no subjects available

Phase II Thrombotic Thrombocytopenic Purpura, Acquired trial by University Hospital, Rouen. Stop reason: OTHER/UNKNOWN.

Recommendations of the independent oversight committee.

Phase II Congenital Heart Malformations trial by Dr. F. Köhler Chemie GmbH. Stop reason: OPERATIONAL.

Sponsor Decision

Phase II Heart Failure trial by Eli Lilly and Company. Stop reason: OTHER/UNKNOWN.

An interim was conducted and after review of available data, including efficacy evaluation of heart failure events, Lilly is terminating the study due to low likelihood of study success for this HFpEF patient population.

Phase IV Atrial Fibrillation trial by University of Calgary. Stop reason: OPERATIONAL.

we couldn't recruit enough participants

Phase IV Percutaneous Coronary Intervention trial by The Guthrie Clinic. Stop reason: OPERATIONAL.

Researcher stopped study due to slow accrual rate

Phase III Acute Decompensated Heart Failure trial by Centre Hospitalier Universitaire Dijon. Stop reason: OPERATIONAL.

There was insufficient funding to continue the study in good conditions.

Phase IV Heart Failure Congestive trial by Prisma Health-Upstate. Stop reason: OTHER/UNKNOWN.

Change in Sponsor

Phase II Pulmonary Arterial Hypertension trial by Novartis Pharmaceuticals. Stop reason: OPERATIONAL.

Sponsor Decision

Phase II Heart Failure trial by Novartis Pharmaceuticals. Stop reason: OPERATIONAL.

Sponsor Decision

Phase I Dilated Cardiomyopathy trial by AstraZeneca. Stop reason: SAFETY.

The study has been terminated due to adverse finding in a non-clinical, chronic toxicology study.

Phase II Pulmonary Vascular Disorder trial by Heidelberg University. Stop reason: OPERATIONAL.

Strategic re-prioritization by the IMP supplier. Decision not safety-related.

Phase II Heart Failure trial by Regeneron Pharmaceuticals. Stop reason: OPERATIONAL.

Sponsor decision

Phase II Pulmonary Arterial Hypertension trial by Novartis Pharmaceuticals. Stop reason: OPERATIONAL.

Sponsor Decision

Phase II Hypertension trial by University of California, San Francisco. Stop reason: OPERATIONAL.

Funding limitations.

Phase II Myocardial Perfusion Imaging trial by Sinotau Pharmaceutical Group. Stop reason: OTHER/UNKNOWN.

The main objective of this study has been achieved. Following internal discussions, the sponsor has decided to terminate this study early.

Early Phase I Cardiovascular Diseases trial by University of Utah. Stop reason: OPERATIONAL.

COVID initially delayed plans to begin recruitment of subjects. Subsequently, the departure of a clinical investigator and loss of access to equipment and study subject population resulted in study termination before any subjects were enrolled.

Phase II Heart Failure With Preserved Ejection Fraction trial by Cardior Pharmaceuticals GmbH. Stop reason: OTHER/UNKNOWN.

Transfer of study responsibility and planning

Phase III Preeclampsia trial by The George Washington University Biostatistics Center. Stop reason: OTHER/UNKNOWN.

participants are no longer being examined or receiving intervention

Unknown Arterial Occlusion trial by University of California, Los Angeles. Stop reason: OPERATIONAL.

Initiating PI left our institution.

Unknown Arrhythmia trial by Universitair Ziekenhuis Brussel. Stop reason: OPERATIONAL.

not enough patients were recruited

Phase II Stroke, Acute trial by Maimonides Medical Center. Stop reason: OPERATIONAL.

The protocol is in the process to change due to challenges in recruiting participants (without a treatment arm) which is now reflected in 2024-04-01

Phase II Heart Failure With Preserved Ejection Fraction trial by Palatin Technologies, Inc. Stop reason: OPERATIONAL.

Study cancelled after Part A. Enrollment taking too long.

Phase III Thrombotic Microangiopathies trial by Omeros Corporation. Stop reason: OTHER/UNKNOWN.

Sponsor terminated study

Phase II Coronary Artery Bypass trial by Peking Union Medical College Hospital. Stop reason: OPERATIONAL.

slow enrollment and inability to reach the planned sample size within the expected timeframe

Phase III Essential Arterial Hypertension trial by EMS. Stop reason: OTHER/UNKNOWN.

Decided by Sponsor

Phase III Arterial Hypertension trial by EMS. Stop reason: OTHER/UNKNOWN.

Decided by Sponsor

Phase II Immune Mediated Anemia trial by National Heart, Lung, and Blood Institute (NHLBI). Stop reason: OPERATIONAL.

Clinical trial was halted prematurely due to low enrollment

Phase II Endothelial Dysfunction trial by Massachusetts General Hospital. Stop reason: OPERATIONAL.

Lack of funding

Phase II Cardiovascular Diseases trial by Massachusetts General Hospital. Stop reason: OPERATIONAL.

Lack of funding

Phase I Friedreich Ataxia trial by Astellas Gene Therapies. Stop reason: OPERATIONAL.

Corporate decision to withdraw the trial at this time.

Phase II Thrombocytopenia, Immune trial by Veralox Therapeutics. Stop reason: OPERATIONAL.

Veralox Therapeutics Business Decision.

Phase II Prevention of Venous Thrombosis After TKA trial by Shanghai Hengrui Pharmaceutical Co., Ltd.. Stop reason: OTHER/UNKNOWN.

Adjustment of the sponsor's R\&D strategy

Phase IV Brain Injuries, Acute trial by University of North Carolina, Chapel Hill. Stop reason: OPERATIONAL.

Low recruitment

Phase II Refractory Angina trial by Imbria Pharmaceuticals, Inc.. Stop reason: OPERATIONAL.

Coronavirus pandemic

Phase II Immune Mediated Anemia trial by National Heart, Lung, and Blood Institute (NHLBI). Stop reason: OTHER/UNKNOWN.

No responders in parent protocol 000758; this follow-on protocol not activated and PI leaving NIH

Unknown Atrial Fibrillation trial by Brian O'Neill MD. Stop reason: OPERATIONAL.

Lack of Funding

Phase IV Atrial Fibrillation trial by Tulane University School of Medicine. Stop reason: OPERATIONAL.

Sponsor withdrew funding

Phase II Uncontrolled Hypertension trial by Regeneron Pharmaceuticals. Stop reason: OPERATIONAL.

Sponsor decision

Phase III Myelofibrosis trial by Incyte Corporation. Stop reason: EFFICACY/FUTILITY.

The study was terminated due to futility.

Phase II Immune Thrombocytopenia (ITP) trial by Novartis Pharmaceuticals. Stop reason: OPERATIONAL.

Business decision

Phase III Myelofibrosis trial by Incyte Corporation. Stop reason: EFFICACY/FUTILITY.

The study was terminated due to futility.

Phase II Ischemic Heart Disease trial by Helixmith Co., Ltd.. Stop reason: OTHER/UNKNOWN.

Company decided not to move forward with this study.

Phase I Myocardial Ischemia trial by Helixmith Co., Ltd.. Stop reason: OPERATIONAL.

The study was never initiated at any sites.

Phase I Heart Failure With Reduced Ejection Fraction (HFrEF) trial by AstraZeneca. Stop reason: OPERATIONAL.

The Sponsor encountered difficulties in recruiting patients for clinical trial D8330C00004 and decided to end the study earlier for business reasons not affecting the benefit-risk balance.

Phase I Renal Impairment trial by AstraZeneca. Stop reason: OPERATIONAL.

Sponsor Decision

Phase I Hypertension trial by Arnatar Therapeutics, Inc.. Stop reason: OTHER/UNKNOWN.

At Sponsor's Request

Phase I Pregnancy Induced Hypertension trial by The University of Texas Medical Branch, Galveston. Stop reason: OTHER/UNKNOWN.

At the request of the PI