Efficacy of Targeted Medical Therapy in Angina and Nonobstructive Coronary Arteries (MVP-ANOCA)

Stanford University

Status and phase: Enrolling; Phase 3; Phase 2

Conditions: Vasospastic Angina; Microvascular Angina; Myocardial Bridge of Coronary Artery; Angina Pectoris

Treatments: Drug: Placebo; Drug: Nebivolol; Drug: Amlodipine

Study type: Interventional

Funder types: Other

Identifiers

NCT06424834

24POST1189688 (Other Grant/Funding Number)

IRB-75085

Details and patient eligibility

About

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.

Enrollment: 150 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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150 participants in 2 patient groups, including a placebo group

Targeted medical therapy

Experimental group

Description:

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.

Treatment:

Drug: Nebivolol

Drug: Amlodipine

Placebo

Placebo Comparator group

Description:

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.

Treatment:

Drug: Placebo