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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00566891
First Posted: December 4, 2007
Last Update Posted: February 2, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
S. Anna Hospital
  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 Phase
Coronary Artery Disease Drug: tirofiban Drug: Clopidogrel Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Safety of High-dose Tirofiban in Patient Undergoing Coronary Angioplasty.

Resource links provided by NLM:


Further study details as provided by S. Anna Hospital:

Primary Outcome Measures:
  • Measure: all cause mortality [ Time Frame: one year ]

Secondary Outcome Measures:
  • measure: major bleeding [ Time Frame: one year ]

Enrollment: 2000
Study Start Date: December 2007
Study Completion Date: February 2009
Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: A
Tirofiban
Drug: tirofiban
tirofiban high dose bolus 25µ/Kg
Other Name: Aggrastat
Placebo Comparator: B
Clopidogrel
Drug: Clopidogrel

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients undergoing percutaneous coronary angioplasty

Exclusion Criteria:

  • Known allergy to tirofiban
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00566891


Locations
Italy
S Anna Hospital
Catanzaro, Italy, 88100
Sponsors and Collaborators
S. Anna Hospital
Investigators
Principal Investigator: Michele Schiariti, MD University of Roma La Sapienza
  More Information

Responsible Party: S Anna Hospital
ClinicalTrials.gov Identifier: NCT00566891     History of Changes
Other Study ID Numbers: SHA-1-2007
First Submitted: November 30, 2007
First Posted: December 4, 2007
Last Update Posted: February 2, 2011
Last Verified: February 2009

Keywords provided by S. Anna Hospital:
percutaneous coronary angioplasty
pci
tirofiban
side effects

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Clopidogrel
Tirofiban
Platelet Aggregation Inhibitors
Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Fibrinolytic Agents
Fibrin Modulating Agents


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