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Recruiting NCT06424834

Efficacy of Targeted Medical Therapy in Angina and Nonobstructive Coronary Arteries

Phase II / Phase III Interventional Angina Pectoris Microvascular Angina Vasospastic Angina Myocardial Bridge of Coronary Artery

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Amlodipine, Nebivolol, Placebo.
Who it may be relevant to
Registry conditions: Angina Pectoris, Microvascular Angina, Vasospastic Angina, Myocardial Bridge of Coronary Artery. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • Drug Amlodipine
    Amlodipine taken once orally daily at a starting dose of 2.5mg, uptitrated to a maximum of 10mg if tolerated.
  • Drug Nebivolol
    Nebivolol taken once orally daily at a starting dose of 5mg, uptitrated to a maximum of 20mg if tolerated.
  • Drug Placebo
    Placebo taken once orally daily.

Primary outcome measures

  • Seattle Angina Questionnaire summary score [Time frame: 5-7 weeks (depending on drug titration period)]
Secondary outcome measures (12)
  • 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]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Treatment

Study locations

United States · 1 center
  • Stanford Hospital — Palo Alto

Identifiers

NCT: NCT06424834 · IRB-75085 · 24POST1189688

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗