Comparing single and dual antiplatelet therapies after heart surgery
Single Versus Dual Antiplatelet Therapy in Patients With Incomplete Revascularization After Coronary Artery Bypass Graft Surgery
This study tests whether taking one or two types of blood-thinning medications after heart surgery helps patients who haven't had all their blood vessels fixed live longer and healthier.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 800 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Campus Bio-Medico University Academic / other |
| Locations | 1 site (Rome) |
| Trial ID | NCT03789916 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include patients who have undergone CABG and have been identified as having incomplete myocardial revascularization.
Not a fit: Patients with acute coronary syndrome within the last 12 months or those who cannot tolerate the medications involved will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into the optimal antiplatelet therapy for patients with incomplete revascularization, potentially improving long-term cardiac outcomes.
How similar studies have performed: Previous studies have explored antiplatelet therapies in similar contexts, but this specific comparison of SAPT versus DAPT in incomplete revascularization is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Rome
- Università Campus Bio-Medico di Roma — Rome, Italy (Recruiting)
Study contacts
- Study coordinator: Antonio Nenna, MD
- Email: a.nenna@unicampus.it
- Phone: +393337014743
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.