Clinical trial NCT06424834: Efficacy of Targeted Medical Therapy in Angina and Nonobstructive Coronary Arteries
Official title: A Randomized Controlled Study of Targeted Medical Therapy Versus Placebo for Angina and Non- Obstructive Coronary Arteries: The MVP-ANOCA Study
Conditions: Angina Pectoris
Microvascular Angina
Vasospastic Angina
Myocardial Bridge of Coronary Artery
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.
Interventions:
description: Amlodipine taken once orally daily at a starting dose of 2.5mg, uptitrated to a maximum of 10mg if tolerated.
name: Amlodipine
other_name: Katerzia
Norliqva
Norvasc
type: Drug
description: Nebivolol taken once orally daily at a starting dose of 5mg, uptitrated to a maximum of 20mg if tolerated.
name: Nebivolol
other_name: Bystolic
type: Drug
description: Placebo taken once orally daily.
name: Placebo
type: Drug
Study arms:
design_group_description: 1. Epicardial or microvascular coronary spasm: Amlodipine 2.5mg initial dose, 10mg max dose<br/>2. Coronary microvascular dysfunction: Nebivolol 5mg initial dose, 20mg max dose<br/>3. Myocardial Bridge: Nebivolol 5mg initial dose, 20mg max dose<br/>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<br/>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.
design_group_title: Targeted medical therapy
design_group_type: Experimental
design_group_description: 1. Epicardial or microvascular coronary spasm: Placebo<br/>2. Coronary microvascular dysfunction: Placebo<br/>3. Myocardial Bridge: Placebo<br/>4. Mixed epicardial/microvascular spasm and coronary microvascular dysfunction/myocardial bridge: Placebo<br/>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.
design_group_title: Placebo
design_group_type: Placebo Comparator
Sponsor: Stanford University
Collaborators: American Heart Association, Inc.
Drug name mappings:
name: 盐酸奈必洛尔
lang: CN
name: Nebivolol hydrochloride
lang: EN
name: 苯磺酸氨氯地平
lang: CN
name: Amlodipine Besylate
lang: EN
name: アムロジピンベシル酸塩
lang: JP