The SHINE-CTO Trial (SHINE-CTO)
Coronary Artery Disease, Chronic Total Occlusion of Coronary Artery, Percutaneous Transluminal Coronary Angioplasty
About this trial
This is an interventional treatment trial for Coronary Artery Disease
Eligibility Criteria
Inclusion Criteria:
- Age 18 years or greater
- Willing and able to give informed consent. The patients must be able to comply with study procedures and follow-up.
- Referred for clinically-indicated CTO PCI
- Optimal medical therapy (at least two anti-anginal medications at maximum tolerated doses, aspirin, and statin)
Exclusion Criteria:
- Coexisting conditions that limit life expectancy to less than 6 months or that could affect a patient's compliance with the protocol
- Recent (<7 days) acute myocardial infarction
- Patient has no symptoms related to the CTO
- Known allergy to aspirin or clopidogrel
- Increased risk of bleeding (need for warfarin, oral Xa inhibitor, or thrombin inhibitor administration, recent [within 30 days] major bleed, known bleeding diathesis or coagulation disorder)
- Positive pregnancy test or breast-feeding
- Chronic kidney disease, defined as serum creatinine > 2.5 mg/dL
- Severe peripheral arterial disease limiting exercise capacity
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Active Comparator
Sham Comparator
PCI of CTO
Sham Procedure
Intervention: PCI of CTO (Chronic Total Occlusion Percutaneous Coronary Intervention) Chronic Total Occlusion Percutaneous Coronary Intervention (CTO PCI), as per standard clinical practice. Hospitalized overnight after the procedure, with post procedure monitoring practices as per standard of care for PCI. CTO PCI patients will receive blinded clopidogrel 75 mg daily for 6 months.
Intervention: Sham procedure Subjects will be blinded to randomization assignment using a combination of conscious sedation and sensory isolation (e.g., blindfold and noise isolation). Control subjects will only undergo a "Sham procedure", wherein they will undergo bilateral arterial access, without angiography or PCI being performed. Hospitalized overnight after the procedure, with post procedure monitoring practices as per standard of care for PCI. Sham group will receive blinded placebo clopidogrel for 6 months.