NCT03789916RecruitingPhase 3
SAPT Versus DAPT in Incomplete Revascularization After CABG
Single Versus Dual Antiplatelet Therapy in Patients With Incomplete Revascularization After Coronary Artery Bypass Graft Surgery
Source: ClinicalTrials.gov · Last updated 21 Jul 2022 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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 DAPT will be continued for 12 months, and ticagrelor will be withdrawn thereafter.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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 800 (estimated)
- First submitted
- 27 Dec 2018
- Start date
- 2 Jan 2019
- Primary completion date
- 1 Aug 2021
- Lead sponsor
- Campus Bio-Medico University
- Diseases
- Coronary artery disease
- NCT number
- NCT03789916
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 800
- From 2 Jan 2019 to the primary completion date, 1 Aug 2021
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- dual antiplatelet therapy at hospital admission
- surgical treatment requiring DAPT withdrawn
Other illness
- acute coronary syndrome \< 12 months from surgery
- planned procedure to complete myocardial revascularization (e.g. hybrid approach)
- history of gastrointestinal bleeding
- chronic liver disease
- severe heart failure at hospital admission
- active malignancy
- any clinical condition not compatible with the treatment
- Exit Criteria:
- postoperative hemorrhagic events (stroke, GI bleeding)
Lab values
- chronic kidney disease (eGFR \< 30 mL/min/1.73 m2)
Other
- intolerance / unable to take acetylsalicylic acid or ticagrelor
- preoperative atrial fibrillation
- impaired compliance
- planned pregnancy
- alcohol abuse
- postoperative atrial fibrillation requiring anticoagulation
- occurrence of contraindications to acetylsalicylic acid or ticagrelor
- patient decision
Who the study is looking for
- patients undergoing CABG, ± cardiopulmonary bypass, ± any associated cardiac procedures (valve replacement,...)
- incomplete myocardial revascularization, defined by anatomic or functional criteria
- obtained informed consent
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Università Campus Bio-Medico di Roma Coordinator of this site? Confirm its status | Rome | Italy | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.