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Clinical Trials in Italy / NCT03789916
Recruiting Phase 3

SAPT Versus DAPT in Incomplete Revascularization After CABG

NCT03789916 · tracked via the Priya Life Science Italy tracker
Sponsor
Campus Bio-Medico University
Phase
Phase 3
Started
2019-01-02
Last updated
2022-07-21

Condition(s) studied

Coronary Artery Disease

Investigational drug(s) / intervention(s)

Ticagrelor →acetylsalicylic acid →

Ticagrelor: 90 mg bis in die

acetylsalicylic acid: 100 mg die

Study summary

The study aims to compare the efficacy of dual antiplatelet therapy (DAPT) over single antiplatelet therapy (SAPT) in patients with incomplete revascularization after coronary artery bypass graft surgery (CABG).

Before hospital discharge, patients will be 1:1 randomized to SAPT (acetylsalicylic acid 100 mg/die) or DAPT (acetylsalicylic acid 100 mg/die + ticagrelor 90 mg bis in die). DAPT will be continued for 12 months, and ticagrelor will be withdrawn thereafter. Primary endpoint is the evaluation of cardiac-related mortality at 5 years from hospital discharge.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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bleeding) * occurrence of contraindications to acetylsalicylic acid or ticagrelor * surgical treatment requiring DAPT withdrawn * patient decision

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Università Campus Bio-Medico di Roma Rome Italy Recruiting

On this site

📄 Brilinta (ticagrelor) drug profile →

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT03789916 on ClinicalTrials.gov ↗ ← All trials in Italy