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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-05-17

Study Completion Date

2023-09-17

Brief Summary

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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.

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Detailed Description

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Simple randomization in a 1:1 ratio will be made in blocks of variable size according to a random numbers generated by Excel 2019 to divide the patients to treatment group (Nicorandil and verapamil) and control group (Saline). The primary end points are the incidence of periprocedural myocardial injury and 4a MI and the level of the IMR,secondary end points include levels of hs-cTnI, CK-MB ,NT-proBNP and hs-CRP before, and 24 hours following PCI, and major adverse cardiovascular events at day 30. SPSS 26.0 will be used, and P-value \< .05 will be considered statistically signifificant.

Conditions

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Coronary Artery Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Nicorandil and verapamil

intracoronary of 2mg Nicorandil and 500ug verapamil

Group Type EXPERIMENTAL

Nicorandil

Intervention Type DRUG

Prophylactically combined intracoronary of Nicorandil and verapamil

saline

intracoronary of 4ml saline

Group Type PLACEBO_COMPARATOR

Saline

Intervention Type DRUG

intracoronary of 4ml saline

Interventions

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Nicorandil

Prophylactically combined intracoronary of Nicorandil and verapamil

Intervention Type DRUG

Saline

intracoronary of 4ml saline

Intervention Type DRUG

Other Intervention Names

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verapamil

Eligibility Criteria

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Inclusion Criteria

* 1.diagnosis of CHD with FFR\<0.8;2.elective PCI;

Exclusion Criteria

* Patients with AMI, lesion at the opening of the main coronary artery，kidney dysfunction, Liver dysfunction，blood coagulation disorder ,NYHA III-IV,Degree II-III atrioventricular block,and restenosis after PCI，CABG will be excluded.

Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No