Safety of High-Dose Tirofiban During Coronary Angioplasty - Full Text View

Safety of High-Dose Tirofiban During Coronary Angioplasty (SANTISS)

This study is currently recruiting participants.

Verified by S. Anna Hospital, July 2008

Sponsored by:	S. Anna Hospital
Information provided by:	S. Anna Hospital
ClinicalTrials.gov Identifier:	NCT00566891

Purpose

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

Condition	Intervention
Coronary Artery Disease	Drug: tirofiban

MedlinePlus related topics: Angioplasty Coronary Artery Disease

Drug Information available for: Tirofiban Tirofiban hydrochloride Tirofiban hydrochloride monohydrate

U.S. FDA Resources

Study Type:	Observational
Study Design:	Case-Only, Retrospective
Official Title:	Safety of High-Dose Tirofiban in Patient Undergoing Coronary Angioplasty.

Further study details as provided by S. Anna Hospital:

Primary Outcome Measures:

Measure: all cause mortality [ Time Frame: one year ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

measure: major bleeding [ Time Frame: one year ] [ Designated as safety issue: Yes ]

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	2000
Study Start Date:	December 2007
Estimated Study Completion Date:	December 2008

Groups/Cohorts	Assigned Interventions
A Tirofiban	Drug: tirofiban tirofiban high dose bolus 25µ/Kg
B Control

Show Detailed Description

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

Patients elegible for percutaneouous coronary angioplasty

Criteria

Inclusion Criteria:

Patients undergoing percutaneous coronary angioplasty

Exclusion Criteria:

Known allergy to tirofiban

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00566891

Contacts

Contact: Michele Schiariti, MD

+390649972645

michele.schiariti@uniroma1.it

Locations

Italy
S Anna Hospital	Recruiting
Catanzaro, Italy, 88100
Contact: Michele Schiariti, MD michele.schiariti@uniroma1.it

Sponsors and Collaborators

S. Anna Hospital

Investigators

Principal Investigator:

Michele Schiariti, MD

University of Roma La Sapienza

More Information

Responsible Party:	S Anna Hospital ( S Anna Hospital )
Study ID Numbers:	SHA-1-2007
Study First Received:	November 30, 2007
Last Updated:	July 14, 2008
ClinicalTrials.gov Identifier:	NCT00566891
Health Authority:	Italy: Ministry of Health

Keywords provided by S. Anna Hospital:

percutaneous coronary angioplasty
pci
tirofiban
side effects

Study placed in the following topic categories:

Arterial Occlusive Diseases
Coronary Disease
Heart Diseases
Tirofiban
Myocardial Ischemia

Vascular Diseases
Arteriosclerosis
Ischemia
Coronary Artery Disease

Additional relevant MeSH terms:

Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Therapeutic Uses
Hematologic Agents
Platelet Aggregation Inhibitors

Fibrinolytic Agents
Cardiovascular Diseases
Cardiovascular Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009