Phase 3 Heart Disease Trial, Recruiting NCT03789916 Sponsor: Campus Bio-Medico University Condition: Heart Disease
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Phase 3 Heart Disease Trial, Recruiting

NCT03789916
Recruiting Phase 3

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • People who are having coronary artery bypass graft (CABG) surgery, with or without a heart-lung bypass machine, and with or without other heart procedures such as valve replacement.
  • People whose heart surgery will not fully restore blood flow to all areas of the heart, based on physical or functional assessment.
  • People who have given their written agreement to take part in the trial.

Who may not be able to join:

  • People who had a heart attack or serious chest pain event within the 12 months before their surgery.
  • People who are already taking two blood-thinning medications together at the time they are admitted to hospital.
  • People for whom an additional planned procedure is already scheduled to complete the restoration of blood flow to the heart (for example, a combined surgical and non-surgical approach).
  • People who are unable to take aspirin (acetylsalicylic acid) or ticagrelor, or who have had a bad reaction to either medication.
  • People who have an irregular heart rhythm called atrial fibrillation before their surgery.
  • People who may have difficulty following the trial's instructions or treatment schedule.
  • People who are pregnant or planning to become pregnant.
  • People who have previously experienced bleeding in the stomach or digestive tract.
  • People with significantly reduced kidney function (confirm with trial site for specific measurement details).
  • People with long-term liver disease.
  • People with severe heart failure at the time they are admitted to hospital.
  • People with a currently active cancer diagnosis.
  • People with a history of alcohol misuse.
  • People with any other health condition that the trial site determines is not compatible with the trial treatment.

People already enrolled may be removed from the trial if:

  • They develop an irregular heart rhythm (atrial fibrillation) after surgery that requires blood-thinning treatment.
  • They experience a bleeding event after surgery, such as a bleeding stroke or digestive tract bleeding.
  • A reason arises after surgery that means aspirin or ticagrelor can no longer be safely used.
  • A surgical situation arises that requires the use of two blood-thinning medications, making the trial treatment unsuitable.
  • The participant chooses to withdraw from the trial.

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 16 July 2026
Phase 3: approximately ~65% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Principal Investigator: Massimo Chello, MD, Università Campus Bio-Medico di Roma, Rome, Italy

Phone: +393337014743

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Phase 3
Sponsor
Campus Bio-Medico University
Registry
ClinicalTrials.gov
Start date
2 January 2019
Est. completion
1 August 2021

Where this trial is recruiting

🇮🇹 Italy

Primary endpoints

Cardiac-related mortality

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 16 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov