NCT00566891

Brief Summary

This single-centre study is intended to retrospectively check the safety of high-dose bolus of tirofiban in patients who underwent percutaneous angioplasty.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
2,000

participants targeted

Target at P75+ for phase_4 coronary-artery-disease

Timeline
Completed

Started Dec 2007

Shorter than P25 for phase_4 coronary-artery-disease

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

November 30, 2007

Completed
1 day until next milestone

Study Start

First participant enrolled

December 1, 2007

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 4, 2007

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2008

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2009

Completed
Last Updated

February 2, 2011

Status Verified

February 1, 2009

Enrollment Period

7 months

First QC Date

November 30, 2007

Last Update Submit

February 1, 2011

Conditions

Coronary Artery Disease

Keywords

percutaneous coronary angioplastypcitirofibanside effects

Outcome Measures

Primary Outcomes (1)

  • Measure: all cause mortality

    one year

Secondary Outcomes (1)

  • measure: major bleeding

    one year

Study Arms (2)

A

ACTIVE COMPARATOR

Tirofiban

Drug: tirofiban

B

PLACEBO COMPARATOR

Clopidogrel

Drug: Clopidogrel

Interventions

tirofibanDRUG

tirofiban high dose bolus 25µ/Kg

Also known as: Aggrastat
A
ClopidogrelDRUG
B

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Patients undergoing percutaneous coronary angioplasty

You may not qualify if:

  • Known allergy to tirofiban

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

S Anna Hospital

Catanzaro, 88100, Italy

Location

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

TirofibanClopidogrel

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Intervention Hierarchy (Ancestors)

TyrosineAmino Acids, AromaticAmino Acids, CyclicAmino AcidsAmino Acids, Peptides, and ProteinsTiclopidineThienopyridinesThiophenesSulfur CompoundsOrganic ChemicalsPyridinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • Michele Schiariti, MD

    University of Roma La Sapienza

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 30, 2007

First Posted

December 4, 2007

Study Start

December 1, 2007

Primary Completion

July 1, 2008

Study Completion

February 1, 2009

Last Updated

February 2, 2011

Record last verified: 2009-02

Locations

IT(1)