DANANGINA
The Danish Randomized Sham-Controlled Study of Invasive Versus Medical Treatment for Stable Angina Pectoris
Sponsor study identifier
interventional
450
1 country
1
Study Start
June 15, 2020
Actual (reported)Primary Completion
May 31, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
September 30, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
September 30, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
June 15, 2020
Actual (reported)June 15, 2020
Actual (reported)August 3, 2020
Actual (reported)May 31, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
September 30, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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
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
Conventional PCI and optimal medical therapy
Sham-PCI and optimal medical therapy
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.
Gentofte University Hospital
Gentofte Municipality, Copenhagen, 2900, Denmark
Ole Havndrup
Zealand Unviersity Hospital
Ole Ahlehoff
Odense University Hospital
Ashkan Eftekhari
Aarhus University Hospital Skejby
Martin Kirk
Aalborg University Hospital
Niels Thue Olsen, MD, PhD
CONTACT
First Submitted
June 15, 2020
First Posted
August 3, 2020
Study Start
June 15, 2020
Actual (reported)Primary Completion
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
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Rikke Sørensen
Copenhagen University Hospital, Rigshospitalet
May 31, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
September 30, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
August 3, 2020
Record last verified: 2020-07
Data will be shared upon request.
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Source: ClinicalTrials.gov.
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