Percutaneous Coronary Intervention Versus Medical Treatment for Stable Angina Pectoris

NCT ID: NCT04496648

Last Updated: 2020-08-03

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 450 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-06-15
• Study Completion Date: 2022-09-30

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 optimal medical therapy (OMT) alone. In patients with mild to moderate coronary artery disease the prognostic impact of PCI is probably limited. Furthermore it is unclear which treatment is superior in terms of relieving symptoms (PCI or OMT). In this trial, patients with mild to moderate coronary artery disease will be randomized to PCI or sham-PCI. All patients will undergo optimal medical therapy. It is hypothesized that PCI is superior to sham-PCI in patients with stable angina pectoris undergoing optimal medical therapy in terms of symptom-relief.

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 pectoris) are usually treated by either percutaneous coronary intervention (PCI) or optimal medical therapy (OMT) alone. In patients with mild to moderate coronary artery disease the prognostic impact of PCI is probably limited. Furthermore it is unclear which treatment is superior in terms of relieving symptoms (PCI or OMT). Both treatments are effective in terms of reducing symptoms, but come with potential side effects.

PCI has in previous trials failed to show superiority compared to medical therapy in patients with stable angina pectoris. However, many visually significant lesions do not limit the blood flow significantly to the heart, and stenting such a lesion only exposes the patient to the risk of side effects of intervention. In recent years it has therefore become guideline-recommended practice to perform physiological test to evaluate a potential stenosis. During an angiography this is most often done using fractional flow reserve (FFR).

This study tests the optimal strategy for treatment of angina-symptoms in patients with stable pectoris. PCI is performed with modern stent designs and use of intravascular functional testing (FFR-guided PCI) and compared to sham-PCI.

Conditions

Coronary Heart Disease; Stable Angina; Ischemic Heart Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

Percutaneous Coronary Intervention

Conventional PCI and optimal medical therapy

Group Type: ACTIVE_COMPARATOR

Percutaneous Coronary Intervention

Intervention Type: PROCEDURE

Percutaneous coronary intervention with drug-eluting stents and modern techniques

Sham-percutaneous coronary intervention

Sham-PCI and optimal medical therapy

Group Type: PLACEBO_COMPARATOR

Sham-percutaneous coronary intervention

Intervention Type: PROCEDURE

Sham-PCI procedure for at least 15 minutes that includes shifting the C-arm, reinserting the FFR-wire in the catheter and inflating the device.

Interventions

Percutaneous Coronary Intervention

Percutaneous coronary intervention with drug-eluting stents and modern techniques

Intervention Type: PROCEDURE

Sham-percutaneous coronary intervention

Sham-PCI procedure for at least 15 minutes that includes shifting the C-arm, reinserting the FFR-wire in the catheter and inflating the device.

Intervention Type: PROCEDURE

Other Intervention Names

PCI; sham-PCI

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Herlev and Gentofte Hospital

OTHER

Sponsor Role: lead

Responsible Party

Sune Ammentorp Haahr-Pedersen

Primary Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ole Havndrup

Role: PRINCIPAL_INVESTIGATOR

Zealand Unviersity Hospital

Ole Ahlehoff

Role: PRINCIPAL_INVESTIGATOR

Odense University Hospital

Ashkan Eftekhari

Role: PRINCIPAL_INVESTIGATOR

Aarhus University Hospital Skejby

Martin Kirk

Role: PRINCIPAL_INVESTIGATOR

Aalborg University Hospital

Rikke Sørensen

Role: PRINCIPAL_INVESTIGATOR

Rigshospitalet, Denmark

Locations

Gentofte University Hospital

Gentofte Municipality, Copenhagen, Denmark

Site Status: RECRUITING

Countries

Denmark

Central Contacts

Sune Ammentorp Haahr-Pedersen, MD

Role: CONTACT

sunped01@regionh.dk

+45 38672267 ext. +4530220889

Niels Thue Olsen, MD, PhD

Role: CONTACT

Facility Contacts

Niels Thue Olsen, MD, PhD

Role: primary

niels.thue.olsen@regionh.dk

+45 38 67 25 60

Other Identifiers

H-18009651

Identifier Type: -

Identifier Source: org_study_id