Angina PectorisPhase 2/3MVP-ANOCANCT06424834
Efficacy of Targeted Medical Therapy in Angina and Nonobstructive Coronary Arteries
A Phase 2/3 study testing Amlodipine and Nebivolol in people with Angina Pectoris and Microvascular Angina, run by Stanford University at 1 site in United States.
Trial summary
The goal of this clinical trial is to learn if targeted medical therapy will improve symptoms and quality of life in patients with angina and non-obstructive coronary arteries compared to placebo, after the underlying cause of the chest pain has been ascertained by coronary function testing. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Angina Pectoris, Microvascular Angina, Vasospastic Angina
- What is being tested?
- Amlodipine and Nebivolol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Oct 2024to Dec 2026
- Phase
- Phase 2/3
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All patients with stable angina referred to the Stanford University Hospital cardiac catheterization laboratory for clinically indicated coronary function testing are eligible for inclusion into the study.
- Specific inclusion criteria for randomization:
- Absence of significant epicardial coronary artery disease on angiography
- Fractional flow reserve > 0.80
- And ≥ 1 of the following:
- Epicardial coronary spasm on acetylcholine testing
Show all 10Show fewer
- Microvascular spasm on acetylcholine testing
- Coronary flow reserve < 2.5
- Index of microcirculatory resistance ≥ 25
- Myocardial bridge on intravascular ultrasound with dobutamine resting full-cycle ratio ≤ 0.76
Who cannot join
- Acute coronary syndrome less than one week prior to enrolment
- Cardiomyopathy
- Contraindications to beta-blockers or calcium channel blockers
- Baseline systolic blood pressure < 95 mmHg
- Baseline heart rate < 55 bpm
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Stanford Hospital
Palo Alto, California, 94304
Christopher Wong, MBBS, PhD, 650-725-5909, ccywong@stanford.edu
Jennifer Tremmel, MD
About this study
Official title: A Randomized Controlled Study of Targeted Medical Therapy Versus Placebo for Angina and Non- Obstructive Coronary Arteries: The MVP-ANOCA Study
The goal of this clinical trial is to learn if targeted medical therapy will improve symptoms and quality of life in patients with angina and non-obstructive coronary arteries compared to placebo, after the underlying cause of the chest pain has been ascertained by coronary function testing.
Participants will be treated with either medications that target the underlying cause of their chest pain or placebo for 4 weeks after a drug titration phase of 1-3 weeks. They will be asked to complete a series of questionnaires to evaluate their quality of life at the beginning and end of the study.
- Conditions
- Angina Pectoris, Microvascular Angina, Vasospastic Angina, Myocardial Bridge of Coronary Artery
- Being tested
- Amlodipine, Nebivolol, Placebo
- Medical subject headings
- Angina Pectoris, Microvascular Angina, Angina Pectoris, Variant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AmlodipineDrug
Also called Norvasc, Katerzia, Norliqva
Amlodipine taken once orally daily at a starting dose of 2.5mg, uptitrated to a maximum of 10mg if tolerated.
NebivololDrug
Also called Bystolic
Nebivolol taken once orally daily at a starting dose of 5mg, uptitrated to a maximum of 20mg if tolerated.
PlaceboDrug
Placebo taken once orally daily.
| Study group | Role | What they receive |
|---|---|---|
| Targeted medical therapy | Experimental | 1. Epicardial or microvascular coronary spasm: Amlodipine 2.5mg initial dose, 10mg max dose
2. Coronary microvascular dysfunction: Nebivolol 5mg initial dose, 20mg max dose
3. Myocardial Bridge: Nebivolol 5mg initial dose, 20mg max dose
4. Mixed epicardial/microvascular spasm and coronary microvascular dysfunction/myocardial bridge: Amlodipine 2.5mg initial dose, 10mg max dose; PLUS Nebivolol 5mg initial dose, 20mg max dose
Participants will take their assigned therapy after randomization. Weekly person via in-person visit or telephone is performed to uptitrate therapy to the maximally tolerated dose. After 1-3 weeks, the initial drug titration phase is completed and a final dose reached. Participants are then instructed to take the maximally tolerated dose for an additional 4 weeks to the conclusion of the study. Receives: Drug: Amlodipine; Drug: Nebivolol |
| Placebo | Placebo comparator | 1. Epicardial or microvascular coronary spasm: Placebo
2. Coronary microvascular dysfunction: Placebo
3. Myocardial Bridge: Placebo
4. Mixed epicardial/microvascular spasm and coronary microvascular dysfunction/myocardial bridge: Placebo
Participants will take their assigned therapy after randomization. Weekly person via in-person visit or telephone is performed to uptitrate therapy to the maximally tolerated dose. After 1-3 weeks, the initial drug titration phase is completed and a final dose reached. Participants are then instructed to take the maximally tolerated dose for an additional 4 weeks to the conclusion of the study. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Seattle Angina Questionnaire summary score
Change in Seattle Angina Questionnaire summary score at follow-up compared to baseline. The score ranges from 0 - 100, with a higher score indicating a better outcome.
Measured: 5-7 weeks (depending on drug titration period)
Secondary outcomes (13)
EuroQol 5 dimension - 5L index score
Change in EuroQol 5 dimension score - 5L index score at follow-up compared to baseline. The index ranges from -0.573 to 1.000, with a higher score indicating a better outcome.
Measured: 5-7 weeks (depending on drug titration period)
EuroQol 5 dimension - 5L visual analogue score
Change in EuroQol 5 dimension score - 5L visual analogue score at follow-up compared to baseline. The index ranges from 0 - 100, with a higher score indicating a better outcome.
Measured: 5-7 weeks (depending on drug titration period)
PHQ-4 score
Change in PHQ-4 at follow-up compared to baseline. The score ranges from 0 - 12, with a higher score indicating a worse outcome.
Measured: 5-7 weeks (depending on drug titration period)
Treatment Satisfaction Questionnaire for Medication score
Change in Treatment Satisfaction Questionnaire for Medication score at follow-up compared to baseline. The score ranges from 0 - 100, with a higher score indicating a better outcome.
Measured: 5-7 weeks (depending on drug titration period)
Seattle Angina Questionnaire summary score stratified by specific chest pain endotypes
Change in Seattle Angina Questionnaire summary score stratified by specific chest pain endotypes at follow-up compared to baseline. The score ranges from 0 - 100, with a higher score indicating a better outcome.
Measured: 5-7 weeks (depending on drug titration period)
EuroQol 5 dimension - 5L index score stratified by specific chest pain endotypes
EuroQol 5 dimension - 5L index score stratified by specific chest pain endotypes at follow-up compared to baseline. The index ranges from -0.573 to 1.000, with a higher score indicating a better outcome.
Measured: 5-7 weeks (depending on drug titration period)
EuroQol 5 dimensions - 5L visual analogue score stratified by specific chest pain endotypes
EuroQol 5 dimensions - 5L visual analogue score stratified by specific chest pain endotypes at follow-up compared to baseline. The index ranges from 0 - 100, with a higher score indicating a better outcome.
Measured: 5-7 weeks (depending on drug titration period)
PHQ-4 scores stratified by specific chest pain endotypes
PHQ-4 score stratified by specific chest pain endotypes at follow-up compared to baseline. The score ranges from 0 - 12, with a higher score indicating a worse outcome.
Measured: 5-7 weeks (depending on drug titration period)
Treatment Satisfaction Questionnaire for Medication score stratified by specific chest pain endotypes
Treatment Satisfaction Questionnaire for Medication scores stratified by specific chest pain endotypes at follow-up compared to baseline. The score ranges from 0 - 100, with a higher score indicating a better outcome.
Measured: 5-7 weeks (depending on drug titration period)
Seattle Angina Questionnaire summary score stratified by baseline angina frequency
Change in Seattle Angina Questionnaire summary score stratified by baseline angina frequency at at follow-up compared to baseline. The score ranges from 0 - 100, with a higher score indicating a better outcome.
Measured: 5-7 weeks (depending on drug titration period)
Proportion of patients with good response, no angina, and excellent health status
Difference between targeted medical therapy group and placebo group in proportion of patients with good response (Seattle Angina Questionnaire summary score ≥ 10), no angina (Seattle Angina Questionnaire angina frequency score = 100), and excellent health status (Seattle Angina Questionnaire summary score ≥ 75).
Measured: 5-7 weeks (depending on drug titration period)
Safety endpoints
Incidence of bleeding, coronary dissection, stroke, periprocedural myocardial infarction, non-self-limiting arrhythmias during the index coronary function testing procedure
Measured: Baseline
Major adverse cardiac events
Difference between targeted medical therapy group and placebo group in incidence of cardiac death, myocardial infarction, and hospital presentation for unstable angina.
Measured: 5-7 weeks (depending on drug titration period)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2024
- Study start10 Oct 2024
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Angina PectorisStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- 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 2/3
- 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
- Stanford University
- Sponsor type
- University, hospital or other
- Collaborators
- American Heart Association
- Responsible party
- Principal investigator, Christopher Chi-Yuen Wong, Stanford University
- Investigators
- Jennifer Tremmel, MD, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06424834
- Sponsor's protocol ID
- IRB-75085
- Other IDs
- 24POST1189688
- Acronym
- MVP-ANOCA
- Status last verified
- Nov 2024
- First submitted
- 12 May 2024
- Last updated
- 27 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Study of Targeted Medical Therapy Versus Placebo for Angina and Non- Obstructive Coronary Arteries: The MVP-ANOCA Study
- ClinicalTrials.gov ID
- NCT06424834
- Acronym / sponsor ID
- MVP-ANOCA / IRB-75085
- Conditions
- Angina Pectoris, Microvascular Angina, Vasospastic Angina, Myocardial Bridge of Coronary Artery
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Collaborators
- American Heart Association
- Study start
- 10 Oct 2024 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 22 May 2024 (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.
The goal of this clinical trial is to learn if targeted medical therapy will improve symptoms and quality of life in patients with angina and non-obstructive coronary arteries compared to placebo, after the underlying cause of the chest pain has been ascertained by coronary function testing.
Participants will be treated with either medications that target the underlying cause of their chest pain or placebo for 4 weeks after a drug titration phase of 1-3 weeks. They will be asked to complete a series of questionnaires to evaluate their quality of life at the beginning and end of the study.
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 |
|---|---|---|
| Targeted medical therapy | Experimental | Drug: Amlodipine, Drug: Nebivolol1. Epicardial or microvascular coronary spasm: Amlodipine 2.5mg initial dose, 10mg max dose 2. Coronary microvascular dysfunction: Nebivolol 5mg initial dose, 20mg max dose 3. Myocardial Bridge: Nebivolol 5mg initial dose, 20mg max dose 4. Mixed epicardial/microvascular spasm and coronary microvascular dysfunction/myocardial bridge: Amlodipine 2.5mg initial dose, 10mg max dose; PLUS Nebivolol 5mg initial dose, 20mg max dose Participants will take their assigned therapy after randomization. Weekly person via in-person visit or telephone is performed to uptitrate therapy to the maximally tolerated dose. After 1-3 weeks, the initial drug titration phase is completed and a final dose reached. Participants are then instructed to take the maximally tolerated dose for an additional 4 weeks to the conclusion of the study. |
| Placebo | Placebo comparator | Drug: Placebo1. Epicardial or microvascular coronary spasm: Placebo 2. Coronary microvascular dysfunction: Placebo 3. Myocardial Bridge: Placebo 4. Mixed epicardial/microvascular spasm and coronary microvascular dysfunction/myocardial bridge: Placebo Participants will take their assigned therapy after randomization. Weekly person via in-person visit or telephone is performed to uptitrate therapy to the maximally tolerated dose. After 1-3 weeks, the initial drug titration phase is completed and a final dose reached. Participants are then instructed to take the maximally tolerated dose for an additional 4 weeks to the conclusion of the study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- All patients with stable angina referred to the Stanford University Hospital cardiac catheterization laboratory for clinically indicated coronary function testing are eligible for inclusion into the study.
- Absence of significant epicardial coronary artery disease on angiography
- Fractional flow reserve > 0.80
- Epicardial coronary spasm on acetylcholine testing
- Microvascular spasm on acetylcholine testing
Key exclusion criteria (5 listed)
- Acute coronary syndrome less than one week prior to enrolment
- Cardiomyopathy
- Contraindications to beta-blockers or calcium channel blockers
- Baseline systolic blood pressure < 95 mmHg
- Baseline heart rate < 55 bpm
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 |
|---|---|---|
| AmlodipineAlso: Norvasc, Katerzia, NorliqvaAmlodipine taken once orally daily at a starting dose of 2.5mg, uptitrated to a maximum of 10mg if tolerated. | Drug | Targeted medical therapy |
| NebivololAlso: BystolicNebivolol taken once orally daily at a starting dose of 5mg, uptitrated to a maximum of 20mg if tolerated. | Drug | Targeted medical therapy |
| PlaceboPlacebo taken once orally daily. | Drug | Placebo |
Primary outcome
Seattle Angina Questionnaire summary score
Time frame: 5-7 weeks (depending on drug titration period)
Change in Seattle Angina Questionnaire summary score at follow-up compared to baseline. The score ranges from 0 - 100, with a higher score indicating a better outcome.
13 secondary outcomes
EuroQol 5 dimension - 5L index score
Time frame: 5-7 weeks (depending on drug titration period)
EuroQol 5 dimension - 5L visual analogue score
Time frame: 5-7 weeks (depending on drug titration period)
PHQ-4 score
Time frame: 5-7 weeks (depending on drug titration period)
Treatment Satisfaction Questionnaire for Medication score
Time frame: 5-7 weeks (depending on drug titration period)
Seattle Angina Questionnaire summary score stratified by specific chest pain endotypes
Time frame: 5-7 weeks (depending on drug titration period)
EuroQol 5 dimension - 5L index score stratified by specific chest pain endotypes
Time frame: 5-7 weeks (depending on drug titration period)
EuroQol 5 dimensions - 5L visual analogue score stratified by specific chest pain endotypes
Time frame: 5-7 weeks (depending on drug titration period)
PHQ-4 scores stratified by specific chest pain endotypes
Time frame: 5-7 weeks (depending on drug titration period)
Treatment Satisfaction Questionnaire for Medication score stratified by specific chest pain endotypes
Time frame: 5-7 weeks (depending on drug titration period)
Seattle Angina Questionnaire summary score stratified by baseline angina frequency
Time frame: 5-7 weeks (depending on drug titration period)
Proportion of patients with good response, no angina, and excellent health status
Time frame: 5-7 weeks (depending on drug titration period)
Safety endpoints
Time frame: Baseline
Major adverse cardiac events
Time frame: 5-7 weeks (depending on drug titration period)
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 27 Nov 2024.
- Individual participant dataSharing planned: No
Related trials for Angina Pectoris
Recruiting
Invasive Evaluation and Phenotype-Guided Treatment of ANOCA in Women
ANOCA - Angina With Non-obstructive Coronary Arteries, Coronary Microvascular Dysfunction (CMD)
Recruiting
Intracoronary Cryotherapy Effect on Stabilization of Vulnerable Plaque in Patients With Stable Angina or ACS - A Traditional Feasibility Study
Coronary Arterial Disease (CAD), Plaque
Recruiting
Mental Stress Reactivity in Women With CMD
Post-menopause
Recruiting
Multivessel Balloon Occlusion to Investigate Obstructive Coronary Artery Disease and aNgina
Stable Angina, Multivessel Coronary Artery Disease
Active, not recruiting
Safety and Clinical Performance of the Freesolve Resorbable Magnesium Scaffold System in the Treatment of Subjects With Long de Novo Lesions
Coronary Artery Disease, Atherosclerosis of Coronary Artery
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.
Jennifer Tremmel, MD principal investigator
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Amlodipine and Nebivolol in people with Angina Pectoris and Microvascular Angina, run by Stanford University at 1 site in United States.
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 10 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 27 Nov 2024. 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 United States. 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.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 Christopher Wong, MBBS, PhD ((650) 725 5909, ccywong@stanford.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Seattle Angina Questionnaire summary score (time frame: 5-7 weeks (depending on drug titration period)). 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 27 Nov 2024.