Official Title: “Reversal of No-Reflow/Slow-Flow During Percutaneous Coronary Intervention in Patients With Acute Myocardial Infarction--a Prospective Randomized Study Comparing Intracoronary Infusion of Diltiazem, Verapamil and Nitroglycerin”

The purpose of this study is to evaluate the efficacy of three different vasodilators including diltiazem, verapamil and nitroglycerin for reversal of no-reflow/slow-flow during direct percutaneous coronary intervention for acute myocardial infarction.

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study

Study Primary Completion Date: December 2008

No-reflow/slow-flow is a frequent observation during direct PCI for AMI and associated with a poor clinical outcome. The present pharmacological management involves the use of different vasodilators including nitrates, verapamil, adenosine and nicorandil. But no randomized trial has been conducted to assess any of these agents, or to determine the appropriate dosage.

This prospective randomized study aimed to confirm favorable effects of diltiazem on no-reflow/slow-flow during direct PCI for AMI compared with verapamil and nitroglycerin.

Intervention(s) in this Clinical Trial

• Drug: Diltiazem
  • Intracoronary Infusion 400-2000ug
• Drug: Verapamil
  • Intracoronary Infusion 200-1000ug
• Drug: Nitroglycerin
  • Intracoronary Infusion 200-1000ug

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: D
  • If no-reflow/slow-flow phenomenon was observed post-PCI, intracoronary infusion of diltiazem via an infusion microcatheter distal to the angioplasty site was performed.
• Active Comparator: V
  • If no-reflow/slow-flow phenomenon was observed post-PCI, intracoronary infusion of verapamil via an infusion microcatheter distal to the angioplasty site was performed.
• Active Comparator: N
  • If no-reflow/slow-flow phenomenon was observed post-PCI, intracoronary infusion of nitroglycerin via an infusion microcatheter distal to the angioplasty site was performed.

Primary Measures

• Vessel flow using TIMI flow grade and TIMI frame count
  • Time Frame: post-PCI
    Safety Issue?: Yes

Secondary Measures

• major adverse cardiovascular events (MACE)
  • Time Frame: within the first 30 days after PCI
    Safety Issue?: No

Inclusion Criteria:

• Clinical diagnosis of acute myocardial infarction
• Vessel TIMI flow < grade Ⅲ post-PCI

Exclusion Criteria:

• Heart failure of New York Heart Association (NYHA) class Ⅲ to class Ⅳ
• Sick sinus syndrome
• Atrioventricular block (grade Ⅱ and above)
• SBP ≤ 90mmHg or cardiogenic shock
• Heart Rate ≤60 bpm
• Pregnancy
• Renal or hepatic failure

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 80 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Fudan University

Overall Clinical Trial Officials and Contacts

Junbo Ge, M.D. Principal Investigator Zhongshan hospital, Fudan University  

Overall Contact: Dong Huang, M.D. 86-21-64041990 huang.dong@zs-hospital.sh.cn

Information obtained from ClinicalTrials.gov on September 05, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00712894

Study ID Number: Zhongshan 2006-70

ClinicalTrials.gov Identifier: NCT00712894

Health Authority: China: Ministry of Health