Comparing single and dual antiplatelet therapies after heart surgery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study compares the effectiveness of single antiplatelet therapy (SAPT) versus dual antiplatelet therapy (DAPT) in patients who have undergone coronary artery bypass grafting (CABG) and have incomplete revascularization. Participants will be randomly assigned to receive either SAPT or DAPT before hospital discharge, with DAPT being administered for 12 months. The primary goal is to evaluate cardiac-related mortality five years after discharge.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* patients undergoing CABG, ± cardiopulmonary bypass, ± any associated cardiac procedures (valve replacement,...)
* incomplete myocardial revascularization, defined by anatomic or functional criteria
* obtained informed consent

Exclusion Criteria:

* acute coronary syndrome \< 12 months from surgery
* dual antiplatelet therapy at hospital admission
* planned procedure to complete myocardial revascularization (e.g. hybrid approach)
* intolerance / unable to take acetylsalicylic acid or ticagrelor
* preoperative atrial fibrillation
* impaired compliance
* planned pregnancy
* history of gastrointestinal bleeding
* chronic kidney disease (eGFR \< 30 mL/min/1.73 m2)
* chronic liver disease
* severe heart failure at hospital admission
* active malignancy
* alcohol abuse
* any clinical condition not compatible with the treatment

Exit Criteria:

* postoperative atrial fibrillation requiring anticoagulation
* postoperative hemorrhagic events (stroke, GI bleeding)
* occurrence of contraindications to acetylsalicylic acid or ticagrelor
* surgical treatment requiring DAPT withdrawn
* patient decision

Where it's running

• Università Campus Bio-Medico di Roma
  Rome, Italy Recruiting

Study contacts

• Study coordinator: Antonio Nenna, MD
• Email: a.nenna@unicampus.it
• Phone: +393337014743

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.