Recruiting
Phase 2
Phase 3

Targeted Medical Therapy

Sponsor:

Stanford University

Code:

NCT06424834

Conditions

Angina Pectoris

Microvascular Angina

Vasospastic Angina

Myocardial Bridge of Coronary Artery

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Amlodipine

Nebivolol

Placebo

Study Details

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 ID

NCT06424834

Start date

Oct 10, 2024

Status verified date

Nov, 2024

Completion date

Dec, 2026

Anticipated

Primary completion date

Dec, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 < 2.5
  • 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

Study Design

Enrollment

150 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: 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.

placebo comparator: 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.

Interventions

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.

Primary outcome measure

  • Seattle Angina Questionnaire summary score [ Time Frame: 5-7 weeks (depending on drug titration period) ]

Central Contacts and Locations

Central contacts

Christopher Wong, MBBS, PhD

(650) 725 5909ccywong@stanford.edu

Locations

Stanford Hospital

Recruiting

Palo Alto, California, United States, 94304

Contacts

Christopher Wong, MBBS, PhD

650-725-5909ccywong@stanford.edu

Principal Investigator:

Jennifer Tremmel, MD

More Information

Sponsor

Stanford University

Last update posted

Nov 27, 2024

Last verified

Nov, 2024

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Stanford University on 2024-11-27.