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

NCT05399576 | Unknown Phase 2

• 1 other identifier: 2022-KL-085-03
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Coronary Artery Disease

Keywords

periprocedural myocardial injury; coronary microvascular disturbances; percutaneous coronary intervention; nicorandil; verapamil

Outcome Measures

Primary Outcomes (1)

• 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

  Within 24 hours after surgery

Study Arms (2)

Nicorandil and verapamil

EXPERIMENTAL

intracoronary of 2mg Nicorandil and 500ug verapamil

Drug: Nicorandil

saline

PLACEBO COMPARATOR

intracoronary of 4ml saline

Drug: Saline

Interventions

Nicorandil DRUG

Prophylactically combined intracoronary of Nicorandil and verapamil

Also known as: verapamil

Nicorandil and verapamil

Saline DRUG

intracoronary of 4ml saline

saline

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• The First Affiliated Hospital of Zhejiang Chinese Medical University: lead

Study Sites (1)

yuangang Qiu

Hangzhou, Zhejiang, 310006, China

RECRUITING

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

Nicorandil; Verapamil; Sodium Chloride

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Nitrates; Organic Chemicals; Niacinamide; Nicotinic Acids; Acids, Heterocyclic; Heterocyclic Compounds; Pyridines; Heterocyclic Compounds, 1-Ring; Phenethylamines; Ethylamines; Amines; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Central Study Contacts

yuangang Qiu, doctor

CONTACT

18069785911; 13957120120@163.com

chuqun lv, master

CONTACT

18705815970; 1783236712@qq.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 27, 2022
• First Posted: June 1, 2022
• Study Start: May 17, 2022
• Primary Completion: May 17, 2023
• Study Completion: September 17, 2023
• Last Updated: June 1, 2022

Record last verified: 2022-05

Locations

CN (1)