The SHINE-CTO Trial

Not Applicable

Withdrawn

• Conditions: Percutaneous Transluminal Coronary Angioplasty; Chronic Total Occlusion of Coronary Artery; Coronary Artery Disease
• Interventions: Procedure: Chronic Total Occlusion Percutaneous Coronary Intervention; Procedure: Sham Procedure

• Registration Number: NCT02784418
• Lead Sponsor: Minneapolis Heart Institute Foundation

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2016-05
• Study First Submitted: 2016-05-20
• Study First Submitted QC: 2016-05-24
• Study First Posted: 2016-05-27
• Primary Completion: 2020-12
• Status Verified: 2021-06
• Last Update Submitted: 2021-06-02
• Last Update Posted: 2021-06-07
• Study Completion: 2021-12

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PCI of CTO	Chronic Total Occlusion Percutaneous Coronary Intervention	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.
Sham Procedure	Sham Procedure	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.

Primary Outcome Measures

Name	Time	Method
Greater improvement in disease-specific health status, as assessed by the 7-item Seattle Angina Questionnaire (SAQ) Summary Score (SAQ-7, an established measure of health status in patients with coronary artery disease)	1 month

Secondary Outcome Measures

Name	Time	Method
Similar incidence of major adverse cardiac events (MACE), both peri-procedural and long-term	6 months
Greater improvement in SAQ-7 Summary scores during the entire duration of follow-up using a repeated measures analysis	6 months
Greater improvement in exercise capacity, as assessed by treadmill exercise stress	Prior to and 1 month after index procedure
Greater improvement in individual components of patients' health status, as assessed by the EuroQol-5D (EQ-5D)	Baseline and 6 months
Favorable incremental cost-effectiveness ratio	Through study completion, an average of 6 months
Greater improvement in individual components of patients' health status, as assessed by the SAQ Physical Limitation, Angina Frequency, and Quality of Life domains of the SAQ-7 score	Baseline and 6 months
Greater improvement in individual components of patients' health status, as assessed by the Rose Dyspnea Score	Baseline and 6 months