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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
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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