RecruitingPhase 2Phase 3NCT06424834

Efficacy of Targeted Medical Therapy in Angina and Nonobstructive Coronary Arteries

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


Sponsor

Stanford University

Enrollment

150 participants

Start Date

Oct 10, 2024

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Inclusion Criteria9

  • 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

Exclusion Criteria5

  • 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

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Interventions

DRUGAmlodipine

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

DRUGNebivolol

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

DRUGPlacebo

Placebo taken once orally daily.


Locations(1)

Stanford Hospital

Palo Alto, California, United States

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NCT06424834


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