Autopsy report · NCT00123539

Estrogen Replacement to Reduce Risk of Neurologic Injury After Coronary Artery Bypass Graft Surgery

“DSMB stopped the study based on conclusion of likely futility of treatment on the primary outcome.”

The sponsor’s own words in the registry.

Life of this trial

• Registered 4 years 1 month after it had already started.
• Ran for about 4 years 2 months before it stopped.
• 334 participants enrolled.
• No results are posted on the registry.

Vital statistics

Status

Terminated

Phase

Na

Sponsor

National Heart, Lung, and Blood Institute (NHLBI)

Sponsor type

US National Institutes of Health

Conditions

Coronary Disease; Cardiovascular Diseases; Heart Diseases; Neurologic Manifestations

Interventions

Estrogen Replacement Therapy; Surgery

Participants

334

Sites

1

Countries

United States

Trials that died the same way

• Direct Lysis of Staph Aureus Resistant Pathogen Trial of Exebacase
  “The independent DSMB recommended that the study be stopped for futility following interim efficacy analysis.” (83% match in meaning)
• Pilot Study of Varenicline (Chantix®) in the Treatment of Friedreich's Ataxia
  “The DSMB recommended that the study be stopped as a result of concerns regarding safety and intolerability and insufficient evidence of efficacy.” (77% match in meaning)
• ATG Plus Low-dose PT-Cy for GVHD Prevention
  “DSMB recommended halting the study owing to futility after the first interim analysis in August 2024.” (74% match in meaning)
• High Dose Chemotherapy With Amifostine and Autologous Stem Cell Transplantation for High Risk Relapsed Pediatric Solid Tumors and Brain Tumors
  “The study was terminated as recommended by the DSMB due to inability to meet enrollment goals within the time frame allotted (target of 25 patients over 5 years).” (73% match in meaning)
• Helping HIV Infected Patients in South Africa Adhere to Drug Regimens
  “DSMB stopped trial for futility” (72% match in meaning)

Look deeper

• The official registry record (the source of truth)
• Record history: every change the sponsor made
• Open it in the database

Everything here comes from the current ClinicalTrials.gov record. The timeline uses the record’s dates; dates marked planned are the sponsor’s plans. The cause of death is an automatic, unverified label. This is research information, not medical advice.