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NCT Number: NCT06424834

Efficacy of Targeted Medical Therapy in Angina and Nonobstructive Coronary Arteries

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.

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Key information

Conditions

Angina Pectoris Angina Pectoris, Variant Angina, Unstable Cardiovascular Diseases Chest Pain Heart Diseases Microvascular Angina Myocardial Bridge of Coronary Artery Myocardial Ischemia Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms Vascular Diseases Vasospastic Angina

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Stanford Hospital

Palo Alto, California, 94304, United States

Location status: Recruiting

Location contact

Christopher Wong, MBBS, PhD

CONTACT

[email protected]

650-725-5909

Jennifer Tremmel, MD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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
  • 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

Exclusion criteria

  • 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

Treatment and study plan

Amlodipine

Drug

Amlodipine taken once orally daily at a starting dose of 2.5mg, uptitrated to a maximum of 10mg if tolerated.

Other names: Norvasc, Katerzia, Norliqva

nebivolol

Drug

Nebivolol taken once orally daily at a starting dose of 5mg, uptitrated to a maximum of 20mg if tolerated.

Other names: Bystolic

Placebo

Drug

Placebo taken once orally daily.

Primary outcomes

  1. 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.

Secondary outcomes

  1. EuroQol 5 dimension - 5L index score

    Time frame: 5-7 weeks (depending on drug titration period)

    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.

  2. EuroQol 5 dimension - 5L visual analogue score

    Time frame: 5-7 weeks (depending on drug titration period)

    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.

  3. PHQ-4 score

    Time frame: 5-7 weeks (depending on drug titration period)

    Change in PHQ-4 at follow-up compared to baseline. The score ranges from 0 - 12, with a higher score indicating a worse outcome.

  4. Treatment Satisfaction Questionnaire for Medication score

    Time frame: 5-7 weeks (depending on drug titration period)

    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.

  5. Seattle Angina Questionnaire summary score stratified by specific chest pain endotypes

    Time frame: 5-7 weeks (depending on drug titration period)

    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.

  6. EuroQol 5 dimension - 5L index 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 at follow-up compared to baseline. The index ranges from -0.573 to 1.000, with a higher score indicating a better outcome.

  7. EuroQol 5 dimensions - 5L visual analogue 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 at follow-up compared to baseline. The index ranges from 0 - 100, with a higher score indicating a better outcome.

  8. PHQ-4 scores stratified by specific chest pain endotypes

    Time frame: 5-7 weeks (depending on drug titration period)

    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.

  9. Treatment Satisfaction Questionnaire for Medication score stratified by specific chest pain endotypes

    Time frame: 5-7 weeks (depending on drug titration period)

    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.

  10. Seattle Angina Questionnaire summary score stratified by baseline angina frequency

    Time frame: 5-7 weeks (depending on drug titration period)

    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.

  11. Proportion of patients with good response, no angina, and excellent health status

    Time frame: 5-7 weeks (depending on drug titration period)

    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).

  12. Safety endpoints

    Time frame: Baseline

    Incidence of bleeding, coronary dissection, stroke, periprocedural myocardial infarction, non-self-limiting arrhythmias during the index coronary function testing procedure

  13. Major adverse cardiac events

    Time frame: 5-7 weeks (depending on drug titration period)

    Difference between targeted medical therapy group and placebo group in incidence of cardiac death, myocardial infarction, and hospital presentation for unstable angina.

Study contacts

Contact information is provided by the study sponsor or research team.

Christopher Wong, MBBS, PhD

CONTACT

[email protected]

(650) 725 5909

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Collaborators

  • American Heart Association

Registry information

Official study title

A Randomized Controlled Study of Targeted Medical Therapy Versus Placebo for Angina and Non- Obstructive Coronary Arteries: The MVP-ANOCA Study

Acronym: MVP-ANOCA

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
May 22, 2024
Registry last updated
Nov 27, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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