Efficacy of Targeted Medical Therapy in Angina and Nonobstructive Coronary Arteries

NCT06424834 | Recruiting Phase 2 FDA Drug

• 2 other identifiers: IRB-7508524POST1189688
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Seattle Angina Questionnaire summary score

  Change in Seattle Angina Questionnaire summary score at follow-up compared to baseline. The score ranges from 0 - 100, with a higher score indicating a better outcome.

  5-7 weeks (depending on drug titration period)

Secondary Outcomes (13)

• EuroQol 5 dimension - 5L index score

  5-7 weeks (depending on drug titration period)

• EuroQol 5 dimension - 5L visual analogue score

  5-7 weeks (depending on drug titration period)

• PHQ-4 score

  5-7 weeks (depending on drug titration period)

• Treatment Satisfaction Questionnaire for Medication score

  5-7 weeks (depending on drug titration period)

• Seattle Angina Questionnaire summary score stratified by specific chest pain endotypes

  5-7 weeks (depending on drug titration period)

Study Arms (2)

Targeted medical therapy

EXPERIMENTAL

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.

Drug: Amlodipine; Drug: Nebivolol

Placebo

PLACEBO COMPARATOR

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.

Drug: Placebo

Interventions

Amlodipine DRUG

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

Also known as: Norvasc, Katerzia, Norliqva

Targeted medical therapy

Nebivolol DRUG

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

Also known as: Bystolic

Targeted medical therapy

Placebo DRUG

Placebo taken once orally daily.

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Stanford University: lead
• American Heart Association: collaborator

Study Sites (1)

Stanford Hospital

Palo Alto, California, 94304, United States

RECRUITING

MeSH Terms

Conditions

Angina Pectoris; Microvascular Angina; Angina Pectoris, Variant

Interventions

Amlodipine; Nebivolol

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Chest Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Angina, Unstable

Intervention Hierarchy (Ancestors)

Dihydropyridines; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Benzopyrans; Pyrans; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Jennifer Tremmel, MD

  Stanford University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Christopher Wong, MBBS, PhD

CONTACT

(650) 725 5909; ccywong@stanford.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Postdoc

Study Record Dates

• First Submitted: May 12, 2024
• First Posted: May 22, 2024
• Study Start: October 10, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: November 27, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)