Actively Recruiting
A Randomized Controlled Study of Targeted Medical Therapy Versus Placebo for Angina and Non-Obstructive Coronary Arteries: The MVP-ANOCA Study
Led by Stanford University · Updated on 2024-11-27
150
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
S
Stanford University
Lead Sponsor
A
American Heart Association
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating whether targeted medical therapy can improve symptoms and quality of life in patients who have angina with non-obstructive coronary arteries, compared to placebo. The study focuses on patients whose cause of chest pain has been identified through coronary function testing. This trial is in phase 2 and phase 3 and aims to better understand treatments tailored to specific chest pain causes. Participants are assigned to receive either targeted medications or placebo after randomization. The targeted therapies include amlodipine or nebivolol, or a combination, depending on the type of coronary issue diagnosed. Treatment begins with a 1 to 3 week drug titration phase where doses are increased to the highest tolerated level. After this, participants take their reached dose for an additional 4 weeks. During the study, participants will have weekly visits or telephone calls to monitor their dosing. They will complete questionnaires assessing their quality of life, treatment satisfaction, and symptoms at the start and end of the trial. Researchers will measure outcomes such as angina symptoms using the Seattle Angina Questionnaire and other health scores, as well as track any cardiac events. The total study duration for each participant is between 5 and 7 weeks depending on the titration period.
CONDITIONS
Brief Title
Efficacy of Targeted Medical Therapy in Angina and Nonobstructive Coronary Arteries
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 years or older
- Patients with stable angina referred for clinically indicated coronary function testing
- No significant epicardial coronary artery disease on angiography
- Fractional flow reserve greater than 0.80
- Presence of at least one of the following: epicardial coronary spasm on acetylcholine testing, microvascular spasm on acetylcholine testing, coronary flow reserve less than 2.5, index of microcirculatory resistance 25 or higher, or myocardial bridge with resting full-cycle ratio 0.76 or less on intravascular ultrasound with dobutamine
You will not qualify if you...
- Acute coronary syndrome within one week prior to enrollment
- Cardiomyopathy
- Contraindications to beta-blockers or calcium channel blockers
- Baseline systolic blood pressure less than 95 mmHg
- Baseline heart rate less than 55 beats per minute
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 5 to 7 weeks
Participants take their assigned oral medication daily. Weekly visits, either in-person or by telephone, are conducted to adjust the medication dose to the maximum tolerated level during an initial 1 to 3 week titration period. After titration, participants continue taking the final dose daily for an additional 4 weeks.
Weekly visits (in-person or telephone) for 1 to 3 weeks, then no scheduled visits during the following 4 weeks
Trial Site Locations
Total: 1 location
1
Stanford Hospital
Palo Alto, California, United States, 94304
Actively Recruiting
Research Team
C
Christopher Wong, MBBS, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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