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Tirofiban in Stenting for Long Coronary Lesion (PETITION)

This study is currently recruiting participants.
Verified December 2011 by Shanghai Jiao Tong University School of Medicine
Sponsor:
Information provided by (Responsible Party):
Zhang Qi, MD, Shanghai Jiao Tong University School of Medicine
ClinicalTrials.gov Identifier:
NCT01498003
First received: December 11, 2011
Last updated: December 20, 2011
Last verified: December 2011
History of Changes
  Purpose

Periprocedural myonecrosis or infarction are associated with short, intermediate, and long term adverse outcomes. Previous study indicated 12.6% of patients suffered a peri-procedural CK-MB rise by overlapping use of drug-eluting stents for long coronary lesions. Here the investigators hypothesize that peri-procedural use of tirofiban could reduce the occurrence of periprocedural infarciton in elective patients with long coronary lesions treated by overlapping use of drug-eluting stents.


Condition Intervention Phase
Coronary Artery Disease
 Drug: tirofiban
Drug: normal saline solution
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Safety and Efficacy of Peri-procedural Use of Tirofiban in Elective Percutaneous Coronary Intervention for Long Coronary Lesions With Overlapping Drug-Eluting Stent

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Shanghai Jiao Tong University School of Medicine:

Primary Outcome Measures:
  • periprocedural infarction [ Time Frame: 12h after procedure ] [ Designated as safety issue: No ]
    definition of periprocedural MI is a CK elevation >3 times the upper limit of normal.


Secondary Outcome Measures:
  • major bleeding [ Time Frame: during hospitalization (up to 2 weeks) ] [ Designated as safety issue: Yes ]
    The safety outcome of major bleeding according to the Thrombolysis in Myocardial Infarction (TIMI) definition

  • major adverse cardiac event [ Time Frame: one year after procedure ] [ Designated as safety issue: No ]
    major adverse cardiac event (MACE) includes cardiac death, target vessel revascularization, and re-occurrence of myocardial infarction after discharge


Estimated Enrollment: 738
Study Start Date: November 2011
Estimated Study Completion Date: June 2013
Estimated Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Control group
normal saline was applied to those randomized to control group, with same use as tirofiban
 Drug: normal saline solution
same use as tirofiban
Experimental: Tirofiban group
after angioram, and before guiding catheter engagement: 10μg/kg bolus followed by 0.15μg/kg/min maintenance infusion
 Drug: tirofiban
10μg/kg bolus followed by 0.15μg/kg/min maintenance infusion for 12h
Other Name: Xinweining, Grand Pharmaceutical Group, Wuhan, China

Detailed Description:

According to the results of 12.6% occurrence of peri-procedural myocardial infarction after long stent implantation by previous report[International Journal of Cardiology 2009;134: 231-237], the investigator hypothesize the 50% reduction of peri-procedural MI by using tirofiban. Three hundred and sixty-nine patients in each group are needed to reach 80% of power with α 0.05.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age between 18y~80y, with symptomatic coronary disease
  • At least one lesion length more than 40mm to be treated by overlapping drug-eluting stents in major epicardial coronary vessel

Exclusion Criteria:

  • Aspirin or clopidogrel intolerance
  • Lesions length less than 40mm, or overlapping stent length less than 40mm
  • Bifurcation lesions need to be treated by two stents
  • Patients with acute coronary syndrome and elevated baseline cardiac enzyme (CK-MB)
  • Left ventricular ejection fraction less than 0.35
  • Baseline estimated GFR less than 30
  • Estimated life time less than one year
  • Refuse to sign the informed consent
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01498003

Contacts
Contact: Qi Zhang, PhD 86-21-64370045 ext 665380 zhangqnh@yahoo.com

Locations
China, Shanghai
Ruijin Hospital, Shanghai Jiaotong University School of Medicine Recruiting
Shanghai, Shanghai, China, 200025
Contact: Qi Zhang, PhD     86-21-64370045 ext 665380     zhangqnh@yahoo.com    
Principal Investigator: Qi Zhang, PhD            
Sponsors and Collaborators
Shanghai Jiao Tong University School of Medicine
Investigators
Study Chair: WeiFeng Shen, PhD Ruijin Hospital, Shanghai Jiaotong University School of MEdicine
  More Information

No publications provided

Responsible Party: Zhang Qi, MD, Vice Director of Cath. Lab, Shanghai Jiao Tong University School of Medicine
ClinicalTrials.gov Identifier: NCT01498003     History of Changes
Other Study ID Numbers: 20111211
Study First Received: December 11, 2011
Last Updated: December 20, 2011
Health Authority: China: Food and Drug Administration

Keywords provided by Shanghai Jiao Tong University School of Medicine:
coronary disease
stents
thrombosis
myocardial infarction
prognosis

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Tirofiban
 Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Cardiovascular Agents
Therapeutic Uses
Hematologic Agents
Platelet Aggregation Inhibitors

ClinicalTrials.gov processed this record on May 16, 2013