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OpenTrials
Completed

NCT Number: NCT01498003

Tirofiban in Stenting for Long Coronary Lesion

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.

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Key information

Conditions

Coronary Artery Disease Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Coronary Disease Embolism and Thrombosis Heart Diseases Infarction Ischemia Myocardial Infarction Myocardial Ischemia Necrosis Pathologic Processes Pathological Conditions, Signs and Symptoms Thrombosis Vascular Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Ruijin Hospital, Shanghai Jiaotong University School of Medicine

Shanghai, Shanghai Municipality, 200025, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

tirofiban

Drug

10μg/kg bolus followed by 0.15μg/kg/min maintenance infusion for 12h

Other names: Xinweining, Grand Pharmaceutical Group, Wuhan, China

Normal saline solution

Drug

same use as tirofiban

Primary outcomes

  1. periprocedural infarction

    Time frame: 12h after procedure

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

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Shanghai Jiao Tong University School of Medicine

Other

Registry information

Official study title

Safety and Efficacy of Peri-procedural Use of Tirofiban in Elective Percutaneous Coronary Intervention for Long Coronary Lesions With Overlapping Drug-Eluting Stent

Acronym: PETITION

Important dates

Study start
2011
Primary completion
2014
Study completion
2014
First posted
Dec 23, 2011
Registry last updated
Jul 14, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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