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Effects of Different Vasodilators on Coronary No-reflow During primAry percuTaneous Coronary intErvention in Patients With Acute Myocardial Infarction

Information source: Fudan University
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Acute Myocardial Infarction; Percutaneous Coronary Intervention

Intervention: Diltiazem (Drug); Verapamil (Drug); Nitroglycerin (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Fudan University

Official(s) and/or principal investigator(s):
Junbo Ge, M.D., Principal Investigator, Affiliation: Fudan University


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.

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Vessel flow using TIMI flow grade and TIMI frame count

Secondary outcome:

major adverse cardiovascular events (MACE)

Left ventricular ejection fraction (LVEF) through echocardiography

NT-proBNP levels

incidence of complete ST-segment resolution

peak troponin T level

Detailed description: 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.


Minimum age: 18 Years. Maximum age: 80 Years. Gender(s): Both.


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

Locations and Contacts

Zhongshan Hospital Fudan University, Shanghai, Shanghai 200032, China
Additional Information

Starting date: December 2006
Last updated: September 20, 2012

Page last updated: August 23, 2015

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