A Phase 2/3 interventional study of Amlodipine and Nebivolol in Angina Pectoris, Microvascular Angina and Vasospastic Angina, sponsored by Stanford University. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-11-27.
Sponsored by Stanford University · Phase 2/3, Interventional, and Treatment
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.
Specific inclusion criteria for randomization:
And ≥ 1 of the following:
Exclusion Criteria:
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
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
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
Nebivolol taken once orally daily at a starting dose of 5mg, uptitrated to a maximum of 20mg if tolerated.
Also known as: Bystolic
Placebo taken once orally daily.
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.
Time frame: 5-7 weeks (depending on drug titration period)
EuroQol 5 dimension - 5L index score
Change in EuroQol 5 dimension score - 5L index score at follow-up compared to baseline. The index ranges from -0.573 to 1.000, with a higher score indicating a better outcome.
Time frame: 5-7 weeks (depending on drug titration period)
EuroQol 5 dimension - 5L visual analogue score
Change in EuroQol 5 dimension score - 5L visual analogue score at follow-up compared to baseline. The index ranges from 0 - 100, with a higher score indicating a better outcome.
Time frame: 5-7 weeks (depending on drug titration period)
PHQ-4 score
Change in PHQ-4 at follow-up compared to baseline. The score ranges from 0 - 12, with a higher score indicating a worse outcome.
Time frame: 5-7 weeks (depending on drug titration period)
Treatment Satisfaction Questionnaire for Medication score
Change in Treatment Satisfaction Questionnaire for Medication score at follow-up compared to baseline. The score ranges from 0 - 100, with a higher score indicating a better outcome.
Time frame: 5-7 weeks (depending on drug titration period)
Seattle Angina Questionnaire summary score stratified by specific chest pain endotypes
Change in Seattle Angina Questionnaire summary score stratified by specific chest pain endotypes at follow-up compared to baseline. The score ranges from 0 - 100, with a higher score indicating a better outcome.
Time frame: 5-7 weeks (depending on drug titration period)
EuroQol 5 dimension - 5L index score stratified by specific chest pain endotypes
EuroQol 5 dimension - 5L index score stratified by specific chest pain endotypes at follow-up compared to baseline. The index ranges from -0.573 to 1.000, with a higher score indicating a better outcome.
Time frame: 5-7 weeks (depending on drug titration period)
EuroQol 5 dimensions - 5L visual analogue score stratified by specific chest pain endotypes
EuroQol 5 dimensions - 5L visual analogue score stratified by specific chest pain endotypes at follow-up compared to baseline. The index ranges from 0 - 100, with a higher score indicating a better outcome.
Time frame: 5-7 weeks (depending on drug titration period)
PHQ-4 scores stratified by specific chest pain endotypes
PHQ-4 score stratified by specific chest pain endotypes at follow-up compared to baseline. The score ranges from 0 - 12, with a higher score indicating a worse outcome.
Time frame: 5-7 weeks (depending on drug titration period)
Treatment Satisfaction Questionnaire for Medication score stratified by specific chest pain endotypes
Treatment Satisfaction Questionnaire for Medication scores stratified by specific chest pain endotypes at follow-up compared to baseline. The score ranges from 0 - 100, with a higher score indicating a better outcome.
Time frame: 5-7 weeks (depending on drug titration period)
Seattle Angina Questionnaire summary score stratified by baseline angina frequency
Change in Seattle Angina Questionnaire summary score stratified by baseline angina frequency at at follow-up compared to baseline. The score ranges from 0 - 100, with a higher score indicating a better outcome.
Time frame: 5-7 weeks (depending on drug titration period)
Proportion of patients with good response, no angina, and excellent health status
Difference between targeted medical therapy group and placebo group in proportion of patients with good response (Seattle Angina Questionnaire summary score ≥ 10), no angina (Seattle Angina Questionnaire angina frequency score = 100), and excellent health status (Seattle Angina Questionnaire summary score ≥ 75).
Time frame: 5-7 weeks (depending on drug titration period)
Safety endpoints
Incidence of bleeding, coronary dissection, stroke, periprocedural myocardial infarction, non-self-limiting arrhythmias during the index coronary function testing procedure
Time frame: Baseline
Major adverse cardiac events
Difference between targeted medical therapy group and placebo group in incidence of cardiac death, myocardial infarction, and hospital presentation for unstable angina.
Time frame: 5-7 weeks (depending on drug titration period)
Plan to share: No
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Stanford University