Clinical trial NCT06424834: Efficacy of Targeted Medical Therapy in Angina and Nonobstructive Coronary Arteries
Official title: A Randomized Controlled Study of Targeted Medical Therapy Versus Placebo for Angina and Non- Obstructive Coronary Arteries: The MVP-ANOCA Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
PHASE3
Conditions: Angina Pectoris
Microvascular Angina
Vasospastic Angina
Myocardial Bridge of Coronary Artery
Lead sponsor: Stanford University
Sponsor class: OTHER
Collaborators: name: American Heart Association
First posted: 2024-05-22
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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 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

Primary outcomes:
measure: Seattle Angina Questionnaire summary score
timeFrame: 5-7 weeks (depending on drug titration period)
Secondary outcomes:
measure: EuroQol 5 dimension - 5L index score
timeFrame: 5-7 weeks (depending on drug titration period)
measure: EuroQol 5 dimension - 5L visual analogue score
timeFrame: 5-7 weeks (depending on drug titration period)
measure: PHQ-4 score
timeFrame: 5-7 weeks (depending on drug titration period)
measure: Treatment Satisfaction Questionnaire for Medication score
timeFrame: 5-7 weeks (depending on drug titration period)
measure: Seattle Angina Questionnaire summary score stratified by specific chest pain endotypes
timeFrame: 5-7 weeks (depending on drug titration period)
measure: EuroQol 5 dimension - 5L index score stratified by specific chest pain endotypes
timeFrame: 5-7 weeks (depending on drug titration period)
measure: EuroQol 5 dimensions - 5L visual analogue score stratified by specific chest pain endotypes
timeFrame: 5-7 weeks (depending on drug titration period)
measure: PHQ-4 scores stratified by specific chest pain endotypes
timeFrame: 5-7 weeks (depending on drug titration period)
measure: Treatment Satisfaction Questionnaire for Medication score stratified by specific chest pain endotypes
timeFrame: 5-7 weeks (depending on drug titration period)
measure: Seattle Angina Questionnaire summary score stratified by baseline angina frequency
timeFrame: 5-7 weeks (depending on drug titration period)
measure: Proportion of patients with good response, no angina, and excellent health status
timeFrame: 5-7 weeks (depending on drug titration period)
measure: Safety endpoints
timeFrame: Baseline
measure: Major adverse cardiac events
timeFrame: 5-7 weeks (depending on drug titration period)
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: Stanford Hospital
state: California
Study officials:
affiliation: Stanford University
name: Jennifer Tremmel, MD
role: PRINCIPAL_INVESTIGATOR
References: