NCT05618132

ReACHallenge Trial: Acetylcholine Rechallenge After Pretreatment With Vasoactive Drugs

Stepwise Treatment and Acetylcholine Rechallenge in Vasospastic Angina to Guide Patient-tailored Treatment

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: University Hospital, Antwerp · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The goal of this clinical trial is to assess the feasibility and clinical value of acetylcholine (ACH) rechallenge after intracoronary verapamil +- nitroglycerine in a patient cohort with angina and non-obstructive coronary arteries (ANOCA). The main questions it aims to answer are: * to determine the efficacy of these drugs in treating ACH-induced coronary artery spasm * to determine the efficacy of these drugs in preventing ACH-induced coronary artery spasm The ACH rechallenge will take place during the index coronary function tests in patients with proven ACH-induced vasospastic angina. The study is considered a feasibility study, no control arm is included.

Conditions

• Angina Pectoris, Variant
• Angina Pectoris; Spasm-Induced
• Angina Pectoris With Normal Coronary Arteriogram

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Acetylcholine rechallenge	STEP 1 consists of verapamil 1mg IC. Angiography after 60 seconds, if spasm persists, NTG 200µg IC is given (step 2). If verapamil suppresses spasm, ACH rechallenge (ACHR) is performed after 3 minutes. In STEP 2, patients with persistent spasm after verapamil or with spasm after ACHR receive NTG 200µg IC. Angiography after 60 seconds, if spasm persists, NTG 200µg IC is delivered again. If refractory spasm occurs, atropine 1mg IV is given. Coronary spasm is considered suppressed once ACHR can no longer provoke spasm. NTG 200µg IC is given as final drug regardless of spasm. ACHR consists of ACH 100 or 200µg IC depending on the dose that previously provoked the coronary artery spasm (both microvascular and epicardial spasm).

Timeline

• Start date: 2023-01-09
• Primary completion: 2024-01-01
• Completion: 2024-06-01
• First posted: 2022-11-16
• Last updated: 2023-01-19

Locations

1 site across 1 country: Belgium