Percutaneous Coronary Intervention Versus Medical Treatment for Stable Angina Pectoris
DANANGINA
The Danish Randomized Sham-Controlled Study of Invasive Versus Medical Treatment for Stable Angina Pectoris
1 other identifier
interventional
450
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jun 2020
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 15, 2020
CompletedStudy Start
First participant enrolled
June 15, 2020
CompletedFirst Posted
Study publicly available on registry
August 3, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 31, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
September 30, 2022
CompletedAugust 3, 2020
July 1, 2020
2 years
June 15, 2020
July 29, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Combined endpoint of strategy success
Number of patients without angina (freedom from angina) and without hospital admission for intolerable stable angina pectoris, unstable angina pectoris, or acute myocardial infarction
3 months
Secondary Outcomes (13)
Number of all-cause death, any myocardial infarction, stroke, major bleeding, and severe drug reaction
3 months
Number of conversions to PCI for procedural complication (sham-PCI group)
3 months
Number of patients with hospital admission for intolerable stable angina, unstable angina pectoris, or acute myocardial infarction
3 months
Number of patients in CCS class 1, 2, and 3, respectively, without hospital admission for intolerable stable angina, unstable angina pectoris, or acute myocardial infarction
3 months
Number of patients with clinically driven coronary revascularization
3 months
- +8 more secondary outcomes
Study Arms (2)
Percutaneous Coronary Intervention
ACTIVE COMPARATORConventional PCI and optimal medical therapy
Sham-percutaneous coronary intervention
PLACEBO COMPARATORSham-PCI and optimal medical therapy
Interventions
Percutaneous coronary intervention with drug-eluting stents and modern techniques
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Gentofte University Hospital
Gentofte Municipality, Copenhagen, 2900, Denmark
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ole Havndrup
Zealand Unviersity Hospital
- PRINCIPAL INVESTIGATOR
Ole Ahlehoff
Odense University Hospital
- PRINCIPAL INVESTIGATOR
Ashkan Eftekhari
Aarhus University Hospital Skejby
- PRINCIPAL INVESTIGATOR
Martin Kirk
Aalborg University Hospital
- PRINCIPAL INVESTIGATOR
Rikke Sørensen
Rigshospitalet, Denmark
Central Study Contacts
Niels Thue Olsen, MD, PhD
CONTACT
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Primary Investigator
Study Record Dates
First Submitted
June 15, 2020
First Posted
August 3, 2020
Study Start
June 15, 2020
Primary Completion
May 31, 2022
Study Completion
September 30, 2022
Last Updated
August 3, 2020
Record last verified: 2020-07
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
- Time Frame
- 1 year after publication
- Access Criteria
- Upon request
Data will be shared upon request.