Tirofiban in Stenting for Long Coronary Lesion

NCT01498003 | Completed Phase 4 DMC

• 1 other identifier: 20111211
• Study Type: interventional
• Target: 748
• Locations: 1 country
• Sites: 1

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.

Conditions

Coronary Artery Disease

Keywords

coronary disease; stents; thrombosis; myocardial infarction; prognosis

Outcome Measures

Primary Outcomes (1)

• periprocedural infarction

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

  12h after procedure

Secondary Outcomes (2)

• major bleeding

  during hospitalization (up to 2 weeks)

• major adverse cardiac event

  one year after procedure

Study Arms (2)

Control group

PLACEBO COMPARATOR

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

Drug: normal saline solution

Tirofiban group

EXPERIMENTAL

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

Drug: tirofiban

Interventions

tirofiban DRUG

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

Also known as: Xinweining, Grand Pharmaceutical Group, Wuhan, China

Tirofiban group

normal saline solution DRUG

same use as tirofiban

Control group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Shanghai Jiao Tong University School of Medicine: lead

Study Sites (1)

Ruijin Hospital, Shanghai Jiaotong University School of Medicine

Shanghai, Shanghai Municipality, 200025, China

Location

Related Publications (1)

• 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.

  PMID: 25630513 DERIVED

Related Links

• published results

MeSH Terms

Conditions

Coronary Artery Disease; Coronary Disease; Thrombosis; Myocardial Infarction

Interventions

Tirofiban; Saline Solution

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Tyrosine; Amino Acids, Aromatic; Amino Acids, Cyclic; Amino Acids; Amino Acids, Peptides, and Proteins; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• WeiFeng Shen, PhD

  Ruijin Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Vice Director of Cath. Lab

Study Record Dates

• First Submitted: December 11, 2011
• First Posted: December 23, 2011
• Study Start: November 1, 2011
• Primary Completion: June 1, 2014
• Study Completion: June 1, 2014
• Last Updated: July 14, 2015

Record last verified: 2015-07

Locations

CN (1)