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Intracoronary of Nicorandil and Verapamil to Reduce the Occurrence of Periprocedural Myocardial Injury

NCT05399576 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2022-06-01

No results posted yet for this study

Summary

Percutaneous coronary intervention (PCI) remains the major revascularization strategy for patients with obstructive coronary artery disease (CAD).However,in a substantial number of PCI cases for acute coronary syndrome (ACS) and chronic coronary syndrome (CCS),periprocedural myocardial injury or myocardial infarction (MI) occurs,both these PCI-related complications may be associated with an increased risk of future major adverse cardiovascular events (such as death, re-infarction, and revascularization).The incidence of periprocedural myocardial injury varies according to the different definition and cardiac biomarker .For 4th UDMI criteria with hs-cTn, 78% to 85% patients who undergoing elective PCI may suffer from periprocedural myocardial injury.

Experimental and clinical evidence highlight the abnormalities of the coronary microcirculation is one of the causes of myocardial ischemia.Coronary microvascular disturbances (CMD) have been associated with early stages of atherosclerosis even prior to any angiographic evidence of epicardial coronary stenosis, as well as to other cardiac pathologies such as myocardial hypertrophy and heart failure.

In this study, we try to conduct a double blinded, randomized, placebo-controlled trial，the aim of our trial is: (1) to observe whether the prophylactically intracoronary administration of nicorandil and verapamil could reduce the occurrence of periprocedural myocardial injury and infarction in CAD patients undergoing elective PCI.;(2) to observe whether the prophylactically intracoronary administration of nicorandil and verapamil has protective effect on coronary microcirculation after elective PCI.

Conditions

Interventions

DRUG

Nicorandil

Prophylactically combined intracoronary of Nicorandil and verapamil

DRUG

Saline

intracoronary of 4ml saline

Sponsors & Collaborators

  • The First Affiliated Hospital of Zhejiang Chinese Medical University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-05-17
Primary Completion
2023-05-17
Completion
2023-09-17

Countries

  • China

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05399576 on ClinicalTrials.gov