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Tirofiban in Stenting for Long Coronary Lesion (PETITION)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01498003
Recruitment Status : Completed
First Posted : December 23, 2011
Last Update Posted : July 14, 2015
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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 or disease Intervention/treatment Phase
Coronary Artery Disease Drug: tirofiban Drug: normal saline solution Phase 4

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.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 748 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : November 2011
Primary Completion Date : June 2014
Study Completion Date : June 2014

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. periprocedural infarction [ Time Frame: 12h after procedure ]
    definition of periprocedural MI is a CK elevation >3 times the upper limit of normal.


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

  2. major adverse cardiac event [ Time Frame: one year after procedure ]
    major adverse cardiac event (MACE) includes cardiac death, target vessel revascularization, and re-occurrence of myocardial infarction after discharge


Eligibility Criteria

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01498003


Locations
China, Shanghai
Ruijin Hospital, Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai, China, 200025
Sponsors and Collaborators
Shanghai Jiao Tong University School of Medicine
Investigators
Study Chair: WeiFeng Shen, PhD Ruijin Hospital
More Information

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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
First Posted: December 23, 2011    Key Record Dates
Last Update Posted: July 14, 2015
Last Verified: July 2015

Keywords provided by Zhang Qi, MD, 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
Platelet Aggregation Inhibitors