N/A
Completed N=200
Objective Randomised Blinded Investigation With Optimal Medical Therapy of Angioplasty in Stable Angina
Source: ClinicalTrials.gov NCT02062593 ↗Enrolled (actual)
200
Serious AEs
9.0%
Results posted
Apr 2021
Primary outcomePrimary: Exercise Time on Treadmill — 28.4; 11.8 seconds
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Exercise Time on Treadmill |
28.4; 11.8 | — |
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
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. Informational only — not medical advice.