Coronary Heart DiseaseDANANGINANCT04496648
Percutaneous Coronary Intervention Versus Medical Treatment for Stable Angina Pectoris
A study testing Percutaneous Coronary Intervention in people with Coronary Heart Disease and Stable Angina, run by Herlev and Gentofte Hospital at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Coronary Heart Disease, Stable Angina, Ischemic Heart Disease
- What is being tested?
- Percutaneous Coronary Intervention
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 450 participants
- Where
- 1 siteDenmark
- Study dates
- 15 Jun 2020to 30 Sep 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 12Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
Niels Thue Olsen, MD, PhD contact
Denmark1 site, 1 recruiting
- Recruiting
Gentofte University Hospital
Gentofte Municipality, Copenhagen, 2900
Niels Thue Olsen, MD, PhD, +45 38 67 25 60, niels.thue.olsen@regionh.dk
About this study
Official title: The Danish Randomized Sham-Controlled Study of Invasive Versus Medical Treatment for Stable Angina Pectoris
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.
Read the 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.
- Being tested
- Percutaneous Coronary Intervention, Sham-percutaneous coronary intervention
- Keywords
- Atherosclerosis, Fractional flow reserve, Optimal medical therapy, Antianginal, Percutaneous Coronary Intervention
- Medical subject headings
- Coronary Disease, Angina, Stable, Myocardial Ischemia, Atherosclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Percutaneous Coronary InterventionProcedure or surgery
Also called PCI
Percutaneous coronary intervention with drug-eluting stents and modern techniques
Sham-percutaneous coronary interventionProcedure or surgery
Also called sham-PCI
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.
| Study group | Role | What they receive |
|---|---|---|
| Percutaneous Coronary Intervention | Active comparator | Conventional PCI and optimal medical therapy Receives: Procedure: Percutaneous Coronary Intervention |
| Sham-percutaneous coronary intervention | Placebo comparator | Sham-PCI and optimal medical therapy Receives: Procedure: Sham-percutaneous coronary intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 3 months
Secondary outcomes (13)
Number of all-cause death, any myocardial infarction, stroke, major bleeding, and severe drug reaction
see above
Measured: 3 months
Number of conversions to PCI for procedural complication (sham-PCI group)
see above
Measured: 3 months
Number of patients with hospital admission for intolerable stable angina, unstable angina pectoris, or acute myocardial infarction
see above
Measured: 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
see above
Measured: 3 months
Number of patients with clinically driven coronary revascularization
see above
Measured: 3 months
Change in CCS class
see above
Measured: 3 months
Use of antianginal agents
0, 1, 2, or 3 agents
Measured: 3 months
Quality of life score
5- level EQ-5D (EQ-5D-5L) questionnaire. Each dimension will be scored from 0-5 where a higher score means a better outcome. .
Measured: 3 months
Change in angina-specific quality of life
Seattle Angina Questionnaire 7. Values will range from 0-100 where higher score means better outcome.
Measured: 3 months
Primary composite endpoint in the modified intention-to-treat population
The modified intention-to-treat population is comprised of patients who underwent the study procedure and follow-up without overt or formal unblinding.
Measured: 3 months
Change in CCS class in the modified intention-to-treat population
The modified intention-to-treat population is comprised of patients who underwent the study procedure and follow-up without overt or formal unblinding.
Measured: 3 months
Change in Seattle Angina Questionnaire 7 score in the modified intention-to-treat population
The modified intention-to-treat population is comprised of patients who underwent the study procedure and follow-up without overt or formal unblinding. Values will range from 0-100 where higher score means better outcome.
Measured: 3 months
Change in generic quality of life (EQ-5D-5L) in the modified intention-to-treat population
The modified intention-to-treat population is comprised of patients who underwent the study procedure and follow-up without overt or formal unblinding. Each dimension will be scored from 0-5 where a higher score means a better outcome.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2020
- Study start15 Jun 2020
- Primary completion31 May 2022 (estimated)
- Study completion30 Sep 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Heart DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized patient-blind sham-controlled trial
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 450 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Herlev and Gentofte Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sune Ammentorp Haahr-Pedersen, Herlev and Gentofte Hospital
- Investigators
- Ole Havndrup, Principal investigator, Zealand Unviersity HospitalOle Ahlehoff, Principal investigator, Odense University HospitalAshkan Eftekhari, Principal investigator, Aarhus University Hospital SkejbyMartin Kirk, Principal investigator, Aalborg University HospitalRikke Sørensen, Principal investigator, Copenhagen University Hospital, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04496648
- Sponsor's protocol ID
- H-18009651
- Acronym
- DANANGINA
- Status last verified
- Jul 2020
- First submitted
- 15 Jun 2020
- Last updated
- 3 Aug 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data will be shared upon request.
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Danish Randomized Sham-Controlled Study of Invasive Versus Medical Treatment for Stable Angina Pectoris
- ClinicalTrials.gov ID
- NCT04496648
- Acronym / sponsor ID
- DANANGINA / H-18009651
- Keywords
- Atherosclerosis, Fractional flow reserve, Optimal medical therapy, Antianginal, Percutaneous Coronary Intervention
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 450 participants (estimated)
- Lead sponsor
- Herlev and Gentofte HospitalUniversity, hospital or other
- Study start
- 15 Jun 2020 (actual)
- Primary completion
- 31 May 2022 (estimated)
- Study completion
- 30 Sep 2022 (estimated)
- First posted
- 3 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized patient-blind sham-controlled trial
| Arm | Type | Receives |
|---|---|---|
| Percutaneous Coronary Intervention | Active comparator | Procedure: Percutaneous Coronary InterventionConventional PCI and optimal medical therapy |
| Sham-percutaneous coronary intervention | Placebo comparator | Procedure: Sham-percutaneous coronary interventionSham-PCI and optimal medical therapy |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Percutaneous Coronary InterventionAlso: PCIPercutaneous coronary intervention with drug-eluting stents and modern techniques | Procedure or surgery | Percutaneous Coronary Intervention |
| Sham-percutaneous coronary interventionAlso: sham-PCISham-PCI procedure for at least 15 minutes that includes shifting the C-arm, reinserting the FFR-wire in the catheter and inflating the device. | Procedure or surgery | Sham-percutaneous coronary intervention |
Primary outcome
Combined endpoint of strategy success
Time frame: 3 months
Number of patients without angina (freedom from angina) and without hospital admission for intolerable stable angina pectoris, unstable angina pectoris, or acute myocardial infarction
13 secondary outcomes
Number of all-cause death, any myocardial infarction, stroke, major bleeding, and severe drug reaction
Time frame: 3 months
Number of conversions to PCI for procedural complication (sham-PCI group)
Time frame: 3 months
Number of patients with hospital admission for intolerable stable angina, unstable angina pectoris, or acute myocardial infarction
Time frame: 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
Time frame: 3 months
Number of patients with clinically driven coronary revascularization
Time frame: 3 months
Change in CCS class
Time frame: 3 months
Use of antianginal agents
Time frame: 3 months
Quality of life score
Time frame: 3 months
Change in angina-specific quality of life
Time frame: 3 months
Primary composite endpoint in the modified intention-to-treat population
Time frame: 3 months
Change in CCS class in the modified intention-to-treat population
Time frame: 3 months
Change in Seattle Angina Questionnaire 7 score in the modified intention-to-treat population
Time frame: 3 months
Change in generic quality of life (EQ-5D-5L) in the modified intention-to-treat population
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2020.
- Individual participant dataSharing planned: Yes. Data will be shared upon request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Niels Thue Olsen, MD, PhD contact
Ole Havndrup principal investigator
Zealand Unviersity Hospital
Ole Ahlehoff principal investigator
Odense University Hospital
Ashkan Eftekhari principal investigator
Aarhus University Hospital Skejby
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Percutaneous Coronary Intervention in people with Coronary Heart Disease and Stable Angina, run by Herlev and Gentofte Hospital at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sune Ammentorp Haahr-Pedersen, MD (+45 38672267 ext. +4530220889, sunped01@regionh.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Combined endpoint of strategy success (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2020.