Tirofiban in Stenting for Long Coronary Lesion (PETITION)

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.

Study Overview

• Status: Completed
• Conditions: Coronary Artery Disease
• Intervention / Treatment: Drug: normal saline solution; Drug: tirofiban

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 Type: Interventional
• Enrollment (Actual): 748
• Phase: Phase 4

Contacts and Locations

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200025
      • Ruijin Hospital, Shanghai Jiaotong University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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 Names: Xinweining, Grand Pharmaceutical Group, Wuhan, China

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
periprocedural infarction	definition of periprocedural MI is a CK elevation >3 times the upper limit of normal.	12h after procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
major bleeding	The safety outcome of major bleeding according to the Thrombolysis in Myocardial Infarction (TIMI) definition	during hospitalization (up to 2 weeks)
major adverse cardiac event	major adverse cardiac event (MACE) includes cardiac death, target vessel revascularization, and re-occurrence of myocardial infarction after discharge	one year after procedure

Collaborators and Investigators

• Sponsor: Shanghai Jiao Tong University School of Medicine
• Investigators: Study Chair: WeiFeng Shen, PhD, Ruijin Hospital

Publications and helpful links

General Publications

• 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.

Helpful Links

• published results

Study record dates

Study Major Dates

• Study Start: November 1, 2011
• Primary Completion (Actual): June 1, 2014
• Study Completion (Actual): June 1, 2014

Study Registration Dates

• First Submitted: December 11, 2011
• First Submitted That Met QC Criteria: December 20, 2011
• First Posted (Estimate): December 23, 2011

Study Record Updates

• Last Update Posted (Estimate): July 14, 2015
• Last Update Submitted That Met QC Criteria: July 13, 2015
• Last Verified: July 1, 2015

More Information

Terms related to this study

• Keywords: prognosis; coronary disease; myocardial infarction; stents; thrombosis
• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Coronary Artery Disease; Molecular Mechanisms of Pharmacological Action; Fibrinolytic Agents; Fibrin Modulating Agents; Platelet Aggregation Inhibitors; Tirofiban
• Other Study ID Numbers: 20111211