Randomized Trial to Examine a Differential Therapeutic Response in Symptomatic Patients With Non-… (NCT05294887) | Clinical Trial Compass
UnknownPhase 4
Randomized Trial to Examine a Differential Therapeutic Response in Symptomatic Patients With Non-obstructive Coronary Artery Disease
Germany132 participantsStarted 2022-03-04
Plain-language summary
EXAMINE-CAD-DZHK22 is a prospective, randomized, double-blind, placebo-controlled, crossover trial investigating the efficacy of beta blocker (bisoprolol) and calcium channel blocker (diltiazem) therapy in symptomatic patients with non-obstructed coronary arteries according to coronary physiological testing results.
Who can participate
Age range18 Years – 85 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Age 18 - 85 years
* Recurrent angina symptoms provoked by exercise and/or repeated attacks of angina at rest (both at least for 4 weeks)
* Absence of flow-limiting coronary artery stenosis (as defined by any coronary artery diameter reduction \>50% or fractional flow reserve ≤0.80)
* Left ventricular ejection fraction (LVEF) \>50%
* Written informed consent
Exclusion Criteria:
* Pregnancy, planned pregnancy, or breast-feeding
* Female patients of childbearing potential who are unwilling to use a highly effective contraception method during trial participation according to CTFG. In addition, a negative serum or urine pregnancy test must be available prior to randomization.
* Expected life expectancy \<1 year
* Contraindications to withholding nitrates, calcium channel blockers, and beta blockers for 48 hours before invasive coronary reactivity testing (e.g. clinical need for rate control in case of permanent atrial fibrillation, recurrent angina symptoms without any possibility to wihthold ongoing medication)
* Known hypersensitivity or contraindication to bisoprolol or diltiazem or any of its excipients.
* Concomitant therapy with systemic drugs that are strong inhibitors of both CYP3A4 and P-gp (azole antimycotics such as ketoconazole and itraconazole or HIV protease inhibitors such as ritonavir)
* Concomitant therapy with drugs that are strong CYP3A4 inducers (e.g. carbamazepine, phenytoin, rifampicin, St. John's wort)
* Bradycardia (\<50/min) at ti…
What they're measuring
1
Change in angina symptom severity as measured by the Seattle Angina Questionnaire (SAQ) summary score from each period specific baseline to the end of this period (week 4)
Timeframe: from each period specific baseline to the end of this period, i.e. baseline and 4 weeks; 6 weeks and 10 weeks; 12 weeks and 16 weeks