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

This study has been completed.
Information provided by:
S. Anna Hospital Identifier:
First received: November 30, 2007
Last updated: February 1, 2011
Last verified: February 2009
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:

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
Drug: tirofiban
tirofiban high dose bolus 25µ/Kg
Other Name: Aggrastat
Placebo Comparator: B
Drug: Clopidogrel

  Show Detailed Description


Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Patients undergoing percutaneous coronary angioplasty

Exclusion Criteria:

  • Known allergy to tirofiban
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00566891

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

Responsible Party: S Anna Hospital 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
side effects

Additional relevant MeSH terms:
Coronary Artery Disease
Coronary Disease
Myocardial Ischemia
Arterial Occlusive Diseases
Cardiovascular Diseases
Heart Diseases
Vascular Diseases
Cardiovascular Agents
Fibrin Modulating Agents
Fibrinolytic Agents
Hematologic Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Pharmacologic Actions
Physiological Effects of Drugs
Platelet Aggregation Inhibitors
Purinergic Agents
Purinergic Antagonists
Purinergic P2 Receptor Antagonists
Purinergic P2Y Receptor Antagonists
Therapeutic Uses processed this record on April 27, 2016