Tirofiban in Stenting for Long Coronary Lesion (PETITION)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2011 by Shanghai Jiao Tong University School of Medicine.
Recruitment status was  Recruiting
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

December 11, 2011
December 20, 2011
November 2011
June 2012   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01498003 on ClinicalTrials.gov Archive Site
  • 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
Same as current
Not Provided
Not Provided
 
Tirofiban in Stenting for Long Coronary Lesion
Safety and Efficacy of Peri-procedural Use of Tirofiban in Elective Percutaneous Coronary Intervention for Long Coronary Lesions With Overlapping Drug-Eluting Stent

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.

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Coronary Artery Disease
  • Drug: tirofiban
    10μg/kg bolus followed by 0.15μg/kg/min maintenance infusion for 12h
    Other Name: Xinweining, Grand Pharmaceutical Group, Wuhan, China
  • Drug: normal saline solution
    same use as tirofiban
  • Placebo Comparator: Control group
    normal saline was applied to those randomized to control group, with same use as tirofiban
    Intervention: Drug: normal saline solution
  • Experimental: Tirofiban group
    after angioram, and before guiding catheter engagement: 10μg/kg bolus followed by 0.15μg/kg/min maintenance infusion
    Intervention: Drug: tirofiban
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
738
June 2013
June 2012   (final data collection date for primary outcome measure)

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
Both
18 Years to 80 Years
No
Contact: Qi Zhang, PhD 86-21-64370045 ext 665380 zhangqnh@yahoo.com
China
 
NCT01498003
20111211
Yes
Zhang Qi, MD, Shanghai Jiao Tong University School of Medicine
Shanghai Jiao Tong University School of Medicine
Not Provided
Study Chair: WeiFeng Shen, PhD Ruijin Hospital, Shanghai Jiaotong University School of MEdicine
Shanghai Jiao Tong University School of Medicine
December 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP