Status:
UNKNOWN
Percutaneous Coronary Intervention Versus Medical Treatment for Stable Angina Pectoris
Lead Sponsor:
Herlev and Gentofte Hospital
Conditions:
Coronary Heart Disease
Stable Angina
Eligibility:
All Genders
18-85 years
Phase:
NA
Brief Summary
Patients with ischemic heart disease and symptoms due to lack of oxygen to the heart on exertion (stable angina pectoris) are usually treated by either percutaneous coronary intervention (PCI) or opti...
Detailed Description
Ischemic heart disease (IHD) is a major cause of death and disability worldwide. Patients with ischemic heart disease and symptoms due to lack of oxygen to the heart on exertion (stable angina pectori...
Eligibility Criteria
Inclusion
- Inclusion criteria
- Age 18-85 years
- Patients with stable angina pectoris undergoing elective coronary angiography
- Canadian Cardiovascular Society (CCS) class 2 or 3
- Informed consent
- Lesions in one or more coronary vessels with a diameter \>2.5 mm with FFR-values ≤0.80, and suitable for complete revascularization with PCI.
- Exclusion criteria
- Contraindication to PCI or dual antiplatelet therapy (DAPT)
- Use of or indication for oral anticoagulants (OAC) or novel oral anticoagulants (NOAC)
- Use of clopidogrel
- Life expectancy of less than 2 years
- Severe valvular disease
- Severe comorbidity
- Acute coronary event within the past 12 months
- Left ventricular ejection fraction ≤35%.
- Renal function with estimated glomerular filtration rate (eGFR) \<30 mL/min
- Pregnant or nursing
- Severe coronary artery disease (left main stenosis, 3-vessel disease, proximal left anterior descending stenosis, chronic total occlusion of major vessel)
- Coronary disease where complete revascularization by PCI is considered difficult or impossible.
Exclusion
Key Trial Info
Start Date :
June 15 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 30 2022
Estimated Enrollment :
450 Patients enrolled
Trial Details
Trial ID
NCT04496648
Start Date
June 15 2020
End Date
September 30 2022
Last Update
August 3 2020
Active Locations (1)
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1
Gentofte University Hospital
Gentofte Municipality, Copenhagen, Denmark, 2900