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Calcium Channel Blocker

Targeted Medical Therapy for Angina (MVP-ANOCA Trial)

Phase 2 & 3

Recruiting

Led By Jennifer Tremmel, MD

Research Sponsored by Stanford University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Must not have

Contraindications to beta-blockers or calcium channel blockers

Acute coronary syndrome less than one week prior to enrolment

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 5-7 weeks (depending on drug titration period)

Summary

This trial aims to see if a specific medical treatment can help improve symptoms and quality of life in patients with chest pain and clear arteries, compared to a fake treatment. Participants will receive either the real treatment

Who is the study for?

This trial is for patients with different types of chest pain (angina) linked to heart issues without blocked arteries. They should have undergone tests confirming the cause of their angina. People who can't take part include those with other significant health problems, pregnant women, or individuals currently on certain medications.

What is being tested?

The study aims to see if targeted drugs like Amlodipine and Nebivolol can help improve symptoms and life quality in angina patients compared to a placebo. Participants will be randomly given either medication or a placebo for 50 days while monitoring their well-being through questionnaires.

What are the potential side effects?

Possible side effects from Amlodipine may include swelling, fatigue, and dizziness; Nebivolol might cause slow heartbeat, nausea, and headaches. The placebo should not have active side effects but could trigger reactions based on patient expectations.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I cannot take beta-blockers or calcium channel blockers due to health reasons.

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I have not had a heart attack or severe heart issue in the last week.

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I have been diagnosed with cardiomyopathy.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 5-7 weeks (depending on drug titration period)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~5-7 weeks (depending on drug titration period)

This trial's timeline: 3 weeks for screening, Varies for treatment, and 5-7 weeks (depending on drug titration period) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Seattle Angina Questionnaire summary score

Secondary study objectives

EuroQol 5 dimension - 5L index score

EuroQol 5 dimension - 5L index score stratified by specific chest pain endotypes

EuroQol 5 dimension - 5L visual analogue score

+10 more

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Targeted medical therapyExperimental Treatment2 Interventions

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 II: PlaceboPlacebo Group1 Intervention

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Amlodipine

2004

Completed Phase 4

~40680

Nebivolol

2008

Completed Phase 4

~3180