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Tirofiban in Stenting for Long Coronary Lesion (PETITION)

S

Shanghai Jiao Tong University School of Medicine

Status and phase

Completed
Phase 4

Conditions

Coronary Artery Disease

Treatments

Drug: normal saline solution
Drug: tirofiban

Study type

Interventional

Funder types

Other

Identifiers

NCT01498003
20111211

Details and patient eligibility

About

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.

Full 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.

Enrollment

748 patients

Sex

All

Ages

18 to 80 years old

Volunteers

No 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

748 participants in 2 patient groups, including a placebo group

Control group
Placebo Comparator group
Description:
normal saline was applied to those randomized to control group, with same use as tirofiban
Treatment:
Drug: normal saline solution
Tirofiban group
Experimental group
Description:
after angioram, and before guiding catheter engagement: 10μg/kg bolus followed by 0.15μg/kg/min maintenance infusion
Treatment:
Drug: tirofiban

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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