NCT01181388

Brief Summary

Superselective IRA infusion of tirofiban may improve myocardial reperfusion and reduce bleeding complications in AMI patients.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2010

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2010

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

August 11, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 13, 2010

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2012

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2012

Completed
Last Updated

August 13, 2010

Status Verified

June 1, 2010

Enrollment Period

2 years

First QC Date

August 11, 2010

Last Update Submit

August 12, 2010

Conditions

Outcome Measures

Primary Outcomes (3)

  • Major adverse cardiovascular events

    Infarct size, reinfarction, motality, et.al.

    1 month after PCI

  • Major adverse cardiovascular events

    Infarct size, reinfarction, motality, et.al.

    3 months after PCI

  • Major Adverse Cardiovascular Events

    Infarct size, reinfarction, motality, et.al.

    6 months after PCI

Secondary Outcomes (1)

  • number of participants with bleeding events

    1 month

Study Arms (2)

intra-guide-catheter infusion of tirofiban

ACTIVE COMPARATOR
Procedure: administration of tirofiban by guide catheter

intra-thrombus-aspiration-catheter infusion of tirofiban

EXPERIMENTAL
Procedure: administration of tirofiban by thrombus aspiration catheter in infarct-related artery

Interventions

a bolus of 10ug/kg tirofiban administration via thrombus aspiration catheter followed by 0.1ug/kg/min for 12 hours after PCI

intra-thrombus-aspiration-catheter infusion of tirofiban

a bolus of 10ug/kg tirofiban administration via guide catheter followed by 0.1ug/kg/min for 12 hours after PCI

intra-guide-catheter infusion of tirofiban

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • STEMI patients
  • chest pain for less than 12hr
  • plan to PCI

You may not qualify if:

  • LM lesion
  • stent thrombosis
  • cardiac shock
  • thrombocytopenia
  • allergy to asprin

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

the 28th division, Beijing Anzhen Hospital

Beijing, Beijing Municipality, 100029, China

RECRUITING

MeSH Terms

Conditions

Myocardial Infarction

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Central Study Contacts

Shaoping Wang, MD, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 11, 2010

First Posted

August 13, 2010

Study Start

April 1, 2010

Primary Completion

April 1, 2012

Study Completion

October 1, 2012

Last Updated

August 13, 2010

Record last verified: 2010-06

Locations