TUXEDO-2 India study
Ultra-Thin strUt versus XiencE in a Diabetic pOpulation with Multi-Vessel Disease – 2 – India Study (TUXEDO-2-INDIA)
Objective of the Study:
To evaluate clinical outcomes of contemporary PCI strategies—including stent choice (Supraflex Cruz vs Xience), revascularization approach (Percutaneous Coronary Intervention vs Coronary Artery Bypass Grafting), and antiplatelet therapy (ticagrelor vs prasugrel)—in diabetic patients with multi-vessel disease.
Primary Endpoint for Primary Objective:
Target Lesion Failure at 1-year
Comprising of:
- Cardiac death
- Target-vessel myocardial infarction (TV-MI)
- Ischemia-driven target-lesion revascularization (ID-TLR)
Primary Endpoint for Secondary Objective:
Composite endpoint of all cause death, nonfatal MI, or stroke (Major Adverse Cardiovascular Event)
In the combined PCI arms with that of performance goal derived from the CABG arm of FREEDOM trial at 1-year and yearly up to 5 years
Primary Endpoint for Tertiary Objective:
Composite endpoint between Ticagrelor vs Prasugrel at 1-year
Comprising of:
- Death
- Myocardial Infarction
- Stroke
- Bleeding Academic Research Consortium major bleeding
1800 Patients
Enrolled
Multicenter
66 Sites in India
5 year
Follow-up
Study Details | TUXEDO-2 India | https://ctri.nic.in/Clinicaltrials/pmaindet2.php?EncHid=MzY5NDM=&Enc=&userName=
Study Chairman & Lead Principal Investigator:
Dr. Upendra Kaul
Study Co-Chairman:
Dr. Sripal Bangalore