The SHINE-CTO Trial

Minneapolis Heart Institute Foundation

Status: Withdrawn

Conditions: Coronary Artery Disease; Chronic Total Occlusion of Coronary Artery; Percutaneous Transluminal Coronary Angioplasty

Treatments: Procedure: Sham Procedure; Procedure: Chronic Total Occlusion Percutaneous Coronary Intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT02784418

16-009

Details and patient eligibility

About

Design: Single center, double-blind, sham-controlled trial that will randomize symptomatic patients with a coronary chronic total occlusion (CTO) to CTO percutaneous coronary intervention (PCI) or a sham procedure. All patients will receive optimal medical therapy.

Treatment:CTO PCI, as per standard clinical practice.

Control: Patients randomized to sham-procedure will undergo only bilateral arterial access, without angiography or PCI being performed.

Secondary Endpoints: (1) Greater improvement in SAQ-7 Summary scores during the entire duration of follow-up (6 months) using a repeated measures analysis (2) Greater improvement in individual components of patients' health status (3) Greater improvement in exercise capacity (4) Similar incidence of major adverse cardiac events (MACE), both peri-procedural and long-term

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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0 participants in 2 patient groups

PCI of CTO

Active Comparator group

Description:

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.

Treatment:

Procedure: Chronic Total Occlusion Percutaneous Coronary Intervention

Sham Procedure

Sham Comparator group

Description:

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.

Treatment:

Procedure: Sham Procedure