Efficacy of Targeted Medical Therapy in Angina and Nonobstructive Coronary Arteries

Angina Pectoris Clinical Trial

— MVP-ANOCA  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06424834
• Other study ID #: IRB-75085
• Secondary ID: 24POST1189688
• Status: Not yet recruiting
• Phase: Phase 2/Phase 3
• Start date: July 2024
• Est. completion date: December 2026

Study information

• Verified date: May 2024
• Source: Stanford University
• Contact: Christopher Wong, MBBS, PhD
• Phone: (650) 725 5909
• Email: ccywong[@]stanford.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 50 days. They will be asked to complete a series of questionnaires to evaluate their quality of life at the beginning and end of the study.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 150
• Est. completion date: December 2026
• Est. primary completion date: December 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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 < 2.0
• 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

Related Conditions & MeSH terms

• Angina Pectoris
• Angina Pectoris, Variant
• Microvascular Angina
• Myocardial Bridge of Coronary Artery
• Myocardial Bridging
• Vasospastic Angina

Intervention

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

Locations

Country	Name	City	State
United States	Stanford Hospital	Palo Alto	California

Sponsors (2)

Lead Sponsor	Collaborator
Stanford University	American Heart Association

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Seattle Angina Questionnaire summary score	Change in Seattle Angina Questionnaire summary score at 7 weeks compared to baseline. The score ranges from 0 - 100, with a higher score indicating a better outcome.	7 weeks
Secondary	EuroQol 5 dimension - 5L index score	Change in EuroQol 5 dimension score - 5L index score at 7 weeks compared to baseline. The index ranges from -0.573 to 1.000, with a higher score indicating a better outcome.	7 weeks
Secondary	EuroQol 5 dimension - 5L visual analogue score	Change in EuroQol 5 dimension score - 5L visual analogue score at 7 weeks compared to baseline. The index ranges from 0 - 100, with a higher score indicating a better outcome.	7 weeks
Secondary	PHQ-4 score	Change in PHQ-4 at 7 weeks compared to baseline. The score ranges from 0 - 12, with a higher score indicating a worse outcome.	7 weeks
Secondary	Treatment Satisfaction Questionnaire for Medication score	Change in Treatment Satisfaction Questionnaire for Medication score at 7 weeks compared to baseline. The score ranges from 0 - 100, with a higher score indicating a better outcome.	7 weeks
Secondary	Seattle Angina Questionnaire summary score stratified by specific chest pain endotypes	Change in Seattle Angina Questionnaire summary score at 7 weeks stratified by specific chest pain endotypes at 7 weeks compared to baseline. The score ranges from 0 - 100, with a higher score indicating a better outcome.	7 weeks
Secondary	EuroQol 5 dimension - 5L index score stratified by specific chest pain endotypes	EuroQol 5 dimension - 5L index score at 7 weeks stratified by specific chest pain endotypes at 7 weeks compared to baseline. The index ranges from -0.573 to 1.000, with a higher score indicating a better outcome.	7 weeks
Secondary	EuroQol 5 dimensions - 5L visual analogue score stratified by specific chest pain endotypes	EuroQol 5 dimensions - 5L visual analogue score at 7 weeks stratified by specific chest pain endotypes at 7 weeks compared to baseline. The index ranges from 0 - 100, with a higher score indicating a better outcome.	7 weeks
Secondary	PHQ-4 scores stratified by specific chest pain endotypes	PHQ-4 score at 7 weeks stratified by specific chest pain endotypes at 7 weeks compared to baseline. The score ranges from 0 - 12, with a higher score indicating a worse outcome.	7 weeks
Secondary	Treatment Satisfaction Questionnaire for Medication score stratified by specific chest pain endotypes	Treatment Satisfaction Questionnaire for Medication scores at 7 weeks stratified by specific chest pain endotypes at 7 weeks compared to baseline. The score ranges from 0 - 100, with a higher score indicating a better outcome.	7 weeks
Secondary	Seattle Angina Questionnaire summary score stratified by baseline angina frequency	Change in Seattle Angina Questionnaire summary score stratified by baseline angina frequency at at 7 weeks compared to baseline. The score ranges from 0 - 100, with a higher score indicating a better outcome.	7 weeks
Secondary	Proportion of patients with good response, no angina, and excellent health status	Difference between targeted medical therapy group and placebo group in proportion of patients with good response (Seattle Angina Questionnaire summary score = 10), no angina (Seattle Angina Questionnaire angina frequency score = 100), and excellent health status (Seattle Angina Questionnaire summary score = 75).	7 weeks
Secondary	Safety endpoints	Incidence of bleeding, coronary dissection, stroke, periprocedural myocardial infarction, non-self-limiting arrhythmias during the index coronary function testing procedure	Baseline
Secondary	Major adverse cardiac events	Difference between targeted medical therapy group and placebo group in incidence of cardiac death, myocardial infarction, and hospital presentation for unstable angina.	7 weeks