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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2/Phase 3
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. 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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

⁃ 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

Locations
United States
California
Stanford Hospital
RECRUITING
Palo Alto
Contact Information
Primary
Christopher Wong, MBBS, PhD
ccywong@stanford.edu
(650) 725 5909
Time Frame
Start Date: 2024-10-10
Estimated Completion Date: 2026-12
Participants
Target number of participants: 150
Treatments
Experimental: Targeted medical therapy
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.
Placebo_comparator: Placebo
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.
Related Therapeutic Areas
Sponsors
Leads: Stanford University
Collaborators: American Heart Association

This content was sourced from clinicaltrials.gov