N/A N=200 Randomized Quadruple-blind Treatment

Objective Randomised Blinded Investigation With Optimal Medical Therapy of Angioplasty in Stable Angina

Stable Angina

Bottom Line

View on ClinicalTrials.gov: NCT02062593 ↗

Enrolled (actual)

200

Serious AEs

9.0%

Results posted

Apr 2021

Primary outcome: Primary: Exercise Time on Treadmill — 28.4; 11.8 seconds

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Coronary angioplasty (Procedure)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Imperial College London
Primary completion: Aug 2017

Outcome Measures

Outcome	Result	p-value
PRIMARY Exercise Time on Treadmill	28.4; 11.8	—

Summary

In this study the investigators will use careful scientific blinding of patient and their subsequent healthcare staff so that the investigators can determine exactly how much difference coronary angioplasty makes to symptoms and blood supply to the heart. After the 6 weeks blinded phase, all patients will be unblinded and the patients who had undergone sham procedure will be offered the active therapy.

Eligibility Criteria

Inclusion Criteria

Stable angina and at least 1 lesion with angiographic stenosis ≥70% in a single vessel suitable for stent implantation

Exclusion Criteria

Acute coronary syndrome
Previous coronary artery bypass graft surgery
Left main stem disease
Contraindications to PCI or drug-eluting stent (DES) implantation
Heavily calcified or tortuous vessels
Chronic total occlusion in target vessel
Life expectancy 85yr
Angiographic stenosis ≥ 50% in non-target vessel
Inability to consent

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02062593). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.