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

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. Identifier: NCT00566891
Recruitment Status : Completed
First Posted : December 4, 2007
Last Update Posted : February 2, 2011
Information provided by:
S. Anna Hospital

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.

Condition or disease Intervention/treatment Phase
Coronary Artery Disease Drug: tirofiban Drug: Clopidogrel Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2000 participants
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.
Study Start Date : December 2007
Actual Primary Completion Date : July 2008
Actual Study Completion Date : February 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Angioplasty

Arm Intervention/treatment
Active Comparator: A
Drug: tirofiban
tirofiban high dose bolus 25µ/Kg
Other Name: Aggrastat

Placebo Comparator: B
Drug: Clopidogrel

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

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

Information from the National Library of Medicine

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

Inclusion Criteria:

  • Patients undergoing percutaneous coronary angioplasty

Exclusion Criteria:

  • Known allergy to tirofiban

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 identifier (NCT number): NCT00566891

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S Anna Hospital
Catanzaro, Italy, 88100
Sponsors and Collaborators
S. Anna Hospital
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Principal Investigator: Michele Schiariti, MD University of Roma La Sapienza
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Responsible Party: S Anna Hospital Identifier: NCT00566891    
Other Study ID Numbers: SHA-1-2007
First Posted: December 4, 2007    Key Record Dates
Last Update Posted: February 2, 2011
Last Verified: February 2009
Keywords provided by S. Anna Hospital:
percutaneous coronary angioplasty
side effects
Additional relevant MeSH terms:
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Coronary Artery Disease
Coronary Disease
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Arterial Occlusive Diseases
Vascular Diseases
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