ANOCA - Angina With Non-obstructive Coronary ArteriesPhase 3MOTORSNCT06755801
Nebivolol ANOCA Treatment Randomized Trial
A Phase 3 study testing Nevibolol in people with ANOCA - Angina With Non-obstructive Coronary Arteries and Coronary Microvascular Dysfunction (CMD), run by Spanish Society of Cardiology.
Trial summary
To determine the effectiveness of the beta-blocker nebivolol in controlling symptoms and improving the quality of life in patients with angina and coronary microvascular dysfunction. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- ANOCA - Angina With Non-obstructive Coronary Arteries, Coronary Microvascular Dysfunction (CMD)
- What is being tested?
- Nevibolol
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2025to 30 Sep 2026
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Age 18 years or older.
- Presence of stable angina symptoms, defined as compatible symptoms occurring at least once weekly in the last three months.
- Absence of functionally significant epicardial coronary artery disease (FFR > 0.80).
- Microvascular functional study showing CFR< 2,0 and/or IMR ≥ 25.
Who cannot join
- Allergy or contraindication to the use of beta-blockers.
- Indication for beta-blocker treatment due to another pathology.
- Ventricular dysfunction (LVEF < 45%).
- Percutaneous coronary revascularization in the last 6 months.
- History of surgical revascularization.
- First-degree atrioventricular block or bifascicular block.
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- Presence of hemodynamically significant valvulopathy.
- Presence of cardiomyopathy or congenital cardiac anomaly.
- Severe renal insufficiency (eGFR < 30 ml/min).
- Liver failure (history of cirrhosis or transaminase elevation > 3 times the upper limit of normal).
- Pregnant or lactating women.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Microvascular Obstruction Treatment and Outcomes Randomized Study.
To determine the effectiveness of the beta-blocker nebivolol in controlling symptoms and improving the quality of life in patients with angina and coronary microvascular dysfunction.
Read the detailed description
Objective To determine the effectiveness of the beta-blocker nebivolol in controlling symptoms and improving the quality of life in patients with angina and coronary microvascular dysfunction.
Hypothesis Treatment with titrated nebivolol will result superior to placebo in symptoms control in patients presenting with coronary microvascular disease (CMD).
Study design Prospective, multicenter, controlled, double-blinded, randomized clinical trial.
Inclusion criteria • Patients over 18 years old with symptoms or evidence of myocardial ischemia and coronary arteries without lesions or with epicardial lesions (<50% by visual estimation or FFR >0.80 / RFR >0.90), and
- CFR ≤ 2.0 and/or IMR≥25 Exclusion criteria Life expectancy <1 year, inability to provide informed consent, severe valve disease, left ventricular ejection fraction <30%, clinical contraindication for betablockers treatment.
Treatment arms Randomization will be performed after invasive diagnostic of CMD:
Study group: Nebivolol • Patients will start with a dose of 5 mg every 24 hours. Biweekly dose adjustments will be performed during the first two months, increasing the dose (if tolerated with respect to heart rate, blood pressure, and symptoms) up to a maximum of 20 mg/24 hours.
Control group: Placebo
- Patients will be treated with one tablet every 24 hours. Primary endpoint: The effectiveness of nebivolol treatment in improving angina symptoms was measured using the SAQ questionnaire after 6 months of treatment.
Secondary endpoints • Quality of life at 6 months.
- Functional capacity at 6 months.
- Major cardiac events at 1 year.
- Conditions
- ANOCA - Angina With Non-obstructive Coronary Arteries, Coronary Microvascular Dysfunction (CMD)
- Being tested
- Nevibolol, Placebo
- Keywords
- Coronary Microvascular Disease, Betablockers, Angina
- Medical subject headings
- Microvascular Angina, Angina Pectoris
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NevibololDrug
Beta-blockers are the first-line treatment for patients with stable angina secondary to classic epicardial atherosclerotic disease, where their clinical benefits are well-established (4). However, their efficacy has not yet been demonstrated in ANOCA patients with MVD, where beta-blockers are frequently used due to their physiological plausibility. Beta-blockers act by competitively inhibiting catecholamine receptors. The therapeutic benefits of beta-blockade in patients with stable angina are mediated by a reduction in myocardial oxygen demand. Myocardial oxygen demand depends on heart rate, contractility, and left ventricular wall tension, all of which are reduced with beta-adrenergic blockade. The reduction in wall tension is partly mediated by the antihypertensive action of these drugs. The decrease in heart rate occurs both at rest and during sympathetic activation such as exercise or stress. The negative inotropic effect of these drugs also contributes to reducing myocardial oxyg
PlaceboDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Active treatment group | Experimental | Nevibolol tratment Receives: Drug: Nevibolol |
| Control group | Placebo comparator | Placebo group Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
SAQ questionnaire
The pre-specified primary outcome criterion is the improvement in angina severity assessed by the Seattle Angina Questionnaire (SAQ SS - Summary Score) at 6 months from the start of treatment compared to baseline. It will be evaluated by the mean difference in change within the same patient in SAQ between the two groups at 6 months of treatment.
The SAQ is a validated self-administered scale that allows assessment of angina severity, frequency, quality of life, and functional limitation. It is the most commonly used and validated patient-reported outcome measure for angina. The SAQ provides a scale for evaluating the severity of angina that has been shown to be valid, reproducible, and sensitive to changes.
Measured: 6 months
Secondary outcomes (6)
Quality of Life Status using the EuroQOL questionnaire (EQ5D-5L)
Patient's quality of life in both treatment groups will be assessed using the EuroQOL questionnaire (EQ5D-5L). The EQ5D-5L is the most widely used instrument for assessing health-related quality of life.
Measured: 6 months
the Brief Illness Perception Questionnaire (B-IPQ)
Changes in disease perception will also be recorded using the Brief Illness Perception Questionnaire (B-IPQ)
Measured: 6 months
anxiety and depression using PHQ-4
Quality of Life Status
Measured: 6 months
The treatment satisfaction using the Treatment Satisfaction Questionnaire for Medication (TSQM-9)
Quality of Life Status
Measured: 6 months
Functional Capacity
Functional capacity in both groups will be objectively assessed by performing a baseline and 6-month exercise treadmill test (ergometry) according to the Bruce protocol. The evaluated parameter will be the total duration of maximum exercise (seconds).
Measured: 6 months
Major Cardiac Events
The presence of major cardiac events will be adjudicated by an Independent Events Committee. Major cardiac events are defined as death from any cause, acute myocardial infarction, and hospitalization due to unstable angina, stroke, or heart failure requiring hospitalization.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jan 2025
- Study start1 Apr 2025 (estimated)
- Primary completion30 Mar 2026 (estimated)
- Study completion30 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ANOCA - Angina With Non-obstructive Coronary ArteriesStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Spanish Society of Cardiology
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fernando Alfonso, Spanish Society of Cardiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06755801
- Sponsor's protocol ID
- sec1589634
- Acronym
- MOTORS
- Status last verified
- Dec 2024
- First submitted
- 6 Dec 2024
- Last updated
- 1 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 1 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Microvascular Obstruction Treatment and Outcomes Randomized Study.
- ClinicalTrials.gov ID
- NCT06755801
- Acronym / sponsor ID
- MOTORS / sec1589634
- Conditions
- ANOCA - Angina With Non-obstructive Coronary Arteries, Coronary Microvascular Dysfunction (CMD)
- Keywords
- Coronary Microvascular Disease, Betablockers, Angina
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Spanish Society of CardiologyUniversity, hospital or other
- Study start
- 1 Apr 2025 (estimated)
- Primary completion
- 30 Mar 2026 (estimated)
- Study completion
- 30 Sep 2026 (estimated)
- First posted
- 1 Jan 2025 (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.
To determine the effectiveness of the beta-blocker nebivolol in controlling symptoms and improving the quality of life in patients with angina and coronary microvascular dysfunction.
Detailed description
Objective To determine the effectiveness of the beta-blocker nebivolol in controlling symptoms and improving the quality of life in patients with angina and coronary microvascular dysfunction.
Hypothesis Treatment with titrated nebivolol will result superior to placebo in symptoms control in patients presenting with coronary microvascular disease (CMD).
Study design Prospective, multicenter, controlled, double-blinded, randomized clinical trial.
Inclusion criteria • Patients over 18 years old with symptoms or evidence of myocardial ischemia and coronary arteries without lesions or with epicardial lesions (<50% by visual estimation or FFR >0.80 / RFR >0.90), and
- CFR ≤ 2.0 and/or IMR≥25 Exclusion criteria Life expectancy <1 year, inability to provide informed consent, severe valve disease, left ventricular ejection fraction <30%, clinical contraindication for betablockers treatment.
Treatment arms Randomization will be performed after invasive diagnostic of CMD:
Study group: Nebivolol • Patients will start with a dose of 5 mg every 24 hours. Biweekly dose adjustments will be performed during the first two months, increasing the dose (if tolerated with respect to heart rate, blood pressure, and symptoms) up to a maximum of 20 mg/24 hours.
Control group: Placebo
- Patients will be treated with one tablet every 24 hours. Primary endpoint: The effectiveness of nebivolol treatment in improving angina symptoms was measured using the SAQ questionnaire after 6 months of treatment.
Secondary endpoints • Quality of life at 6 months.
- Functional capacity at 6 months.
- Major cardiac events at 1 year.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active treatment group | Experimental | Drug: NevibololNevibolol tratment |
| Control group | Placebo comparator | Drug: PlaceboPlacebo group |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Age 18 years or older.
Key exclusion criteria (11 listed)
- Allergy or contraindication to the use of beta-blockers.
- Indication for beta-blocker treatment due to another pathology.
- Ventricular dysfunction (LVEF < 45%).
- Percutaneous coronary revascularization in the last 6 months.
- History of surgical revascularization.
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 |
|---|---|---|
| NevibololBeta-blockers are the first-line treatment for patients with stable angina secondary to classic epicardial atherosclerotic disease, where their clinical benefits are well-established (4). However, their efficacy has not yet been demonstrated in ANOCA patients with MVD, where beta-blockers are frequently used due to their physiological plausibility. Beta-blockers act by competitively inhibiting catecholamine receptors. The therapeutic benefits of beta-blockade in patients with stable angina are mediated by a reduction in myocardial oxygen demand. Myocardial oxygen demand depends on heart rate, contractility, and left ventricular wall tension, all of which are reduced with beta-adrenergic blockade. The reduction in wall tension is partly mediated by the antihypertensive action of these drugs. The decrease in heart rate occurs both at rest and during sympathetic activation such as exercise or stress. The negative inotropic effect of these drugs also contributes to reducing myocardial oxyg | Drug | Active treatment group |
| PlaceboPlacebo | Drug | Control group |
Primary outcome
SAQ questionnaire
Time frame: 6 months
The pre-specified primary outcome criterion is the improvement in angina severity assessed by the Seattle Angina Questionnaire (SAQ SS - Summary Score) at 6 months from the start of treatment compared to baseline. It will be evaluated by the mean difference in change within the same patient in SAQ between the two groups at 6 months of treatment. The SAQ is a validated self-administered scale that allows assessment of angina severity, frequency, quality of life, and functional limitation. It is the most commonly used and validated patient-reported outcome measure for angina. The SAQ provides a scale for evaluating the severity of angina that has been shown to be valid, reproducible, and sensitive to changes.
6 secondary outcomes
Quality of Life Status using the EuroQOL questionnaire (EQ5D-5L)
Time frame: 6 months
the Brief Illness Perception Questionnaire (B-IPQ)
Time frame: 6 months
anxiety and depression using PHQ-4
Time frame: 6 months
The treatment satisfaction using the Treatment Satisfaction Questionnaire for Medication (TSQM-9)
Time frame: 6 months
Functional Capacity
Time frame: 6 months
Major Cardiac Events
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jan 2025.
- Individual participant dataSharing planned: Undecided
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Nevibolol in people with ANOCA - Angina With Non-obstructive Coronary Arteries and Coronary Microvascular Dysfunction (CMD), run by Spanish Society of Cardiology.
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 4 inclusion and 11 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: opening soon, as of the sponsor's last update on 1 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact FERNANDO RIVERO, MD,PHD (+34 915202470., hemodinamicaprincesa@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
SAQ questionnaire (time frame: 6 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 1 Jan 2025.