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

This study has been completed.
Sponsor:
Information provided by:
S. Anna Hospital
ClinicalTrials.gov Identifier:
NCT00566891
First received: November 30, 2007
Last updated: February 1, 2011
Last verified: February 2009
History of Changes
  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
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Safety of High-dose Tirofiban in Patient Undergoing Coronary Angioplasty.

Resource links provided by NLM:

U.S. FDA Resources

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 ]

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

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

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

No publications provided

Responsible Party: S Anna Hospital
ClinicalTrials.gov Identifier: NCT00566891     History of Changes
Other Study ID Numbers: SHA-1-2007
Study First Received: November 30, 2007
Last Updated: February 1, 2011
Health Authority: Italy: Ministry of Health

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
Hematologic Agents
 Therapeutic Uses
Pharmacologic Actions
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
Cardiovascular Agents

ClinicalTrials.gov processed this record on May 21, 2013