Efficacy of Targeted Medical Therapy in Angina and Nonobstructive Coronary Arteries

NCT ID: NCT06424834

Last Updated: 2024-11-27

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-10-10
• Study Completion Date: 2026-12-31

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.

Conditions

Angina Pectoris; Microvascular Angina; Vasospastic Angina; Myocardial Bridge of Coronary Artery

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Targeted medical therapy

1. Epicardial or microvascular coronary spasm: Amlodipine 2.5mg initial dose, 10mg max dose

2. Coronary microvascular dysfunction: Nebivolol 5mg initial dose, 20mg max dose

3. Myocardial Bridge: Nebivolol 5mg initial dose, 20mg max dose

4. Mixed epicardial/microvascular spasm and coronary microvascular dysfunction/myocardial bridge: Amlodipine 2.5mg initial dose, 10mg max dose; PLUS Nebivolol 5mg initial dose, 20mg max dose

Participants will take their assigned therapy after randomization. Weekly person via in-person visit or telephone is performed to uptitrate therapy to the maximally tolerated dose. After 1-3 weeks, the initial drug titration phase is completed and a final dose reached. Participants are then instructed to take the maximally tolerated dose for an additional 4 weeks to the conclusion of the study.

Group Type: EXPERIMENTAL

Amlodipine

Intervention Type: DRUG

Amlodipine taken once orally daily at a starting dose of 2.5mg, uptitrated to a maximum of 10mg if tolerated.

Nebivolol

Intervention Type: DRUG

Nebivolol taken once orally daily at a starting dose of 5mg, uptitrated to a maximum of 20mg if tolerated.

Placebo

1. Epicardial or microvascular coronary spasm: Placebo

2. Coronary microvascular dysfunction: Placebo

3. Myocardial Bridge: Placebo

4. Mixed epicardial/microvascular spasm and coronary microvascular dysfunction/myocardial bridge: Placebo

Participants will take their assigned therapy after randomization. Weekly person via in-person visit or telephone is performed to uptitrate therapy to the maximally tolerated dose. After 1-3 weeks, the initial drug titration phase is completed and a final dose reached. Participants are then instructed to take the maximally tolerated dose for an additional 4 weeks to the conclusion of the study.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo taken once orally daily.

Interventions

Amlodipine

Amlodipine taken once orally daily at a starting dose of 2.5mg, uptitrated to a maximum of 10mg if tolerated.

Intervention Type: DRUG

Nebivolol

Nebivolol taken once orally daily at a starting dose of 5mg, uptitrated to a maximum of 20mg if tolerated.

Intervention Type: DRUG

Placebo

Placebo taken once orally daily.

Intervention Type: DRUG

Other Intervention Names

Norvasc; Katerzia; Norliqva; Bystolic

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.

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

American Heart Association

OTHER

Sponsor Role: collaborator

Stanford University

OTHER

Sponsor Role: lead

Responsible Party

Christopher Chi-Yuen Wong

Postdoc

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jennifer Tremmel, MD

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Locations

Stanford Hospital

Palo Alto, California, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Christopher Wong, MBBS, PhD

Role: CONTACT

ccywong@stanford.edu

(650) 725 5909

Facility Contacts

Christopher Wong, MBBS, PhD

Role: primary

ccywong@stanford.edu

650-725-5909

Other Identifiers

24POST1189688

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

IRB-75085

Identifier Type: -

Identifier Source: org_study_id