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Tirofiban in Stenting for Long Coronary Lesion (PETITION)

Primary Purpose

Coronary Artery Disease

Status
Completed
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
tirofiban
normal saline solution
Sponsored by
Shanghai Jiao Tong University School of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronary Artery Disease focused on measuring coronary disease, stents, thrombosis, myocardial infarction, prognosis

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Ruijin Hospital, Shanghai Jiaotong University School of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Control group

Tirofiban group

Arm Description

normal saline was applied to those randomized to control group, with same use as tirofiban

after angioram, and before guiding catheter engagement: 10μg/kg bolus followed by 0.15μg/kg/min maintenance infusion

Outcomes

Primary Outcome Measures

periprocedural infarction
definition of periprocedural MI is a CK elevation >3 times the upper limit of normal.

Secondary Outcome Measures

major bleeding
The safety outcome of major bleeding according to the Thrombolysis in Myocardial Infarction (TIMI) definition
major adverse cardiac event
major adverse cardiac event (MACE) includes cardiac death, target vessel revascularization, and re-occurrence of myocardial infarction after discharge

Full Information

First Posted
December 11, 2011
Last Updated
July 13, 2015
Sponsor
Shanghai Jiao Tong University School of Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT01498003
Brief Title
Tirofiban in Stenting for Long Coronary Lesion
Acronym
PETITION
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 Type
Interventional

2. Study Status

Record Verification Date
July 2015
Overall Recruitment Status
Completed
Study Start Date
November 2011 (undefined)
Primary Completion Date
June 2014 (Actual)
Study Completion Date
June 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shanghai Jiao Tong University School of Medicine

4. Oversight

Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease
Keywords
coronary disease, stents, thrombosis, myocardial infarction, prognosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
748 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control group
Arm Type
Placebo Comparator
Arm Description
normal saline was applied to those randomized to control group, with same use as tirofiban
Arm Title
Tirofiban group
Arm Type
Experimental
Arm Description
after angioram, and before guiding catheter engagement: 10μg/kg bolus followed by 0.15μg/kg/min maintenance infusion
Intervention Type
Drug
Intervention Name(s)
tirofiban
Other Intervention Name(s)
Xinweining, Grand Pharmaceutical Group, Wuhan, China
Intervention Description
10μg/kg bolus followed by 0.15μg/kg/min maintenance infusion for 12h
Intervention Type
Drug
Intervention Name(s)
normal saline solution
Intervention Description
same use as tirofiban
Primary Outcome Measure Information:
Title
periprocedural infarction
Description
definition of periprocedural MI is a CK elevation >3 times the upper limit of normal.
Time Frame
12h after procedure
Secondary Outcome Measure Information:
Title
major bleeding
Description
The safety outcome of major bleeding according to the Thrombolysis in Myocardial Infarction (TIMI) definition
Time Frame
during hospitalization (up to 2 weeks)
Title
major adverse cardiac event
Description
major adverse cardiac event (MACE) includes cardiac death, target vessel revascularization, and re-occurrence of myocardial infarction after discharge
Time Frame
one year after procedure

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
WeiFeng Shen, PhD
Organizational Affiliation
Ruijin Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Ruijin Hospital, Shanghai Jiaotong University School of Medicine
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200025
Country
China

12. IPD Sharing Statement

Citations:
PubMed Identifier
25630513
Citation
Zhang Q, Wang XL, Liao ML, Hu J, Yang ZK, Ding FH, Zhang JS, Du R, Zhu TQ, Shen WF, Zhang RY. Periprocedural use of tirofiban in elective percutaneous coronary intervention for long coronary lesions in stable patients with overlapping drug-eluting stents--the PETITION study: a prospective, randomized, multicenter study. Catheter Cardiovasc Interv. 2015 Mar;85 Suppl 1:762-9. doi: 10.1002/ccd.25864.
Results Reference
derived
Links:
URL
http://www.ncbi.nlm.nih.gov/pubmed/25630513
Description
published results

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Tirofiban in Stenting for Long Coronary Lesion

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