Efficacy of Targeted Medical Therapy in Angina and Nonobstructive Coronary Arteries
Trial statusRecruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorStanford University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Absence of significant epicardial coronary artery disease on angiography
Fractional flow reserve > 0.80
Epicardial coronary spasm on acetylcholine testing
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Amlodipine
DrugAmlodipine taken once orally daily at a starting dose of 2.5mg, uptitrated to a maximum of 10mg if tolerated.
Nebivolol
DrugNebivolol taken once orally daily at a starting dose of 5mg, uptitrated to a maximum of 20mg if tolerated.
Placebo
DrugPlacebo taken once orally daily.
Treatment groups
150 Participants
are divided into 2 treatment groupsGroup A: Targeted medical therapyExperimental treatment 2 interventions
Group B: PlaceboPlacebo comparator 1 intervention
Trial outcomes
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.
Time frame
5-7 weeks (depending on drug titration period)Secondary outcomes
1
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)2
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)3
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)4
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)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Stanford University
Lead sponsor
American Heart Association
Collaborator
Source ClinicalTrials.gov