Efficacy and Safety of Different Dose of Tirofiban in Interventional Treatment of Complex Coronary Artery Disease

NCT02294994 | Unknown Phase 4 DMC

• 1 other identifier: SecondJilinU-1
• Study Type: interventional
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of the study is to investigate the efficacy and safety different dose of GPIIb/IIIa inhibitor (tirofiban) in interventional treatment of complex coronary artery disease ,which include bifurcation lesion, left main lesion, multiple vessel disease, intracoronary thrombus, SYNTAX score\>26,chronic total occlusion disease. The primary endpoint is all-cause mortality. Secondary endpoints are incidence of major bleeding and the rate of site access complication.

Conditions

Coronary Artery Disease

Outcome Measures

Primary Outcomes (1)

• Net Adverse Clinical Events

  A composite of all cause death, reinfarction, urgent target vessel revascularization, stroke and any bleedings

  30 days

Secondary Outcomes (4)

• Net adverse clinical events

  1 year

• any bleedings (BARC class)

  30 days

• Major adverse cardiac and cerebral events (MACCE)

  30 days and 1 year

• stent thrombosis

  30 days and 1 year

Study Arms (3)

half dose tirofiban

EXPERIMENTAL

Tirofiban was administered once the wire had crossed the lesion during PCI with a bolus dose of 25 µg/kg of bodyweight, followed by an infusion of 0.075 µg per kilogram per minute for 24 to 36 hours.UFH heparin was administered as a bolus of 100 U/kg before PCI.

Drug: tirofiban

recommended-dose Tirofiban

ACTIVE COMPARATOR

Tirofiban was administered once the wire had crossed the lesion during PCI with a bolus dose of 25 µg/kg of bodyweight, followed by an infusion of 0.15 µg per kilogram per minute for 18 to 24 hours. UFH heparin was administered as a bolus of 100 U/kg before PCI.

Drug: tirofiban

none tirofiban

PLACEBO COMPARATOR

Tirofiban was not administered ,UFH heparin was administered as a bolus of 100 U/kg before PCI.

Drug: tirofiban

Interventions

tirofiban DRUG

Also known as: GPIIb/IIIa inhibitor, aggrastat

half dose tirofiban; none tirofiban; recommended-dose Tirofiban

Eligibility Criteria

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

You may qualify if:

• Patients were recruited from those undergoing PCI with a planned placement of an intracoronary stent
• Including patients with unstable angina pectoris, acute coronary syndrome or NSTEMI
• Experienced ischaemic pain at rest
• Lasting 10 minutes and occurring within 7 days before enrollment
• As well as one of the following: ECG changes: New or presumably new ST-segment depression greater than or equal to 0.1 mV (1 mm), or transient (\< 30 minutes) ST-segment elevation greater than or equal to 0.1 mV (1 mm) in at least 2 contiguous leads -Abnormal cardiac enzymes within the 24 hours before enrollment, defined as elevated Troponin I defined as elevated Troponin I (above the normal reference -
• High-risk angiographic features :lesion/anatomy related bifurcation lesion, left main lesion, multiple vessel disease, intracoronary thrombus, SYNTAX score \> 26 and chronic total occlusion disease.

You may not qualify if:

• Increased bleeding risk: ischaemic stroke within the last year or any previous haemorrhagic stroke, tumour or intracranial aneurysm;
• Recent (\<1 month) trauma or major surgery (including bypass surgery);
• Active bleeding
• Unexplained clinically significant bleeding, thrombocytopenia (platelet count \< 100 x 109/L) or history of thrombocytopenia with GP IIb/IIIa, heparin or enoxaparin therapy
• Angina from secondary causes such as severe uncontrolled hypertension (systolic blood pressure \> 180 mm Hg despite treatment)
• Valvular disease, congenital heart disease, hypertrophic cardiomyopathy, - Thrombolytic therapy within preceding 24 hours
• Receiving antiIIb/IIIa therapy
• Creatinine clearance of \<30 mL/min

Sponsors & Collaborators

• Second Hospital of Jilin University: lead

Study Sites (1)

The sencond hospital of Jilin University

Changchun, Jilin, 130041, China

RECRUITING

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

Tirofiban

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Tyrosine; Amino Acids, Aromatic; Amino Acids, Cyclic; Amino Acids; Amino Acids, Peptides, and Proteins

Study Officials

• Liu Bin, M.D.

  Jilin University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Liu Bin, M.D.

CONTACT

+86 13500810268; liubin3333@vip.sina.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 16, 2014
• First Posted: November 19, 2014
• Study Start: November 1, 2014
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: December 2, 2014

Record last verified: 2014-11

Locations

CN (1)