Intracoronary of Nicorandil and Verapamil to Reduce the Occurrence of Periprocedural Myocardial Injury
Primary Purpose
Coronary Artery Disease
Status
Recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Nicorandil
Saline
Sponsored by
About this trial
This is an interventional prevention trial for Coronary Artery Disease focused on measuring periprocedural myocardial injury, coronary microvascular disturbances, percutaneous coronary intervention, nicorandil, verapamil
Eligibility Criteria
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.
Sites / Locations
- yuangang QiuRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Nicorandil and verapamil
saline
Arm Description
intracoronary of 2mg Nicorandil and 500ug verapamil
intracoronary of 4ml saline
Outcomes
Primary Outcome Measures
Incidence of periprocedural myocardial injury and infarction after PCI
2.periprocedural myocardial injury was defined as hypersensitive troponin exceeding the upper limit of normal after surgery
Secondary Outcome Measures
Full Information
NCT ID
NCT05399576
First Posted
May 27, 2022
Last Updated
May 27, 2022
Sponsor
The First Affiliated Hospital of Zhejiang Chinese Medical University
1. Study Identification
Unique Protocol Identification Number
NCT05399576
Brief Title
Intracoronary of Nicorandil and Verapamil to Reduce the Occurrence of Periprocedural Myocardial Injury
Official Title
The Preventive Effect of Combined Intracoronary of Nicorandil and Verapamil on Myocardial Injury in Preioperative Period of PCI
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Recruiting
Study Start Date
May 17, 2022 (Actual)
Primary Completion Date
May 17, 2023 (Anticipated)
Study Completion Date
September 17, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The First Affiliated Hospital of Zhejiang Chinese Medical University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
5. Study Description
Brief 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.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease
Keywords
periprocedural myocardial injury, coronary microvascular disturbances, percutaneous coronary intervention, nicorandil, verapamil
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
150 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Nicorandil and verapamil
Arm Type
Experimental
Arm Description
intracoronary of 2mg Nicorandil and 500ug verapamil
Arm Title
saline
Arm Type
Placebo Comparator
Arm Description
intracoronary of 4ml saline
Intervention Type
Drug
Intervention Name(s)
Nicorandil
Other Intervention Name(s)
verapamil
Intervention Description
Prophylactically combined intracoronary of Nicorandil and verapamil
Intervention Type
Drug
Intervention Name(s)
Saline
Intervention Description
intracoronary of 4ml saline
Primary Outcome Measure Information:
Title
Incidence of periprocedural myocardial injury and infarction after PCI
Description
2.periprocedural myocardial injury was defined as hypersensitive troponin exceeding the upper limit of normal after surgery
Time Frame
Within 24 hours after surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
yuangang Qiu, doctor
Phone
18069785911
Email
13957120120@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
chuqun lv, master
Phone
18705815970
Email
1783236712@qq.com
Facility Information:
Facility Name
yuangang Qiu
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310006
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
yuangang Qiu, doctor
Phone
18069785911
Email
13957120120@163.com
First Name & Middle Initial & Last Name & Degree
chuqun Lv
Phone
18705815970
Email
1783236712@qq.com
12. IPD Sharing Statement
Learn more about this trial
Intracoronary of Nicorandil and Verapamil to Reduce the Occurrence of Periprocedural Myocardial Injury
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