RIAPRE - Non-interventional Registry of Anticoagulation Treatment (BI-006-IT)

RIAPRE - A Non-interventional Registry on the Anticoagulation Treatment in High Risk Elective Percutaneous Coronary Interventions

RIAPRE is a non-interventional registry to be settled in Italy with the purpose of collecting data on 600 cases of high risk elective percutaneous coronary intervention (PCI) patients treated with an anticoagulation regime different from unfractionated heparin in monotherapy. About thirty catheterization laboratories will co-operate in this activity. The long term outcome of patients will be taken into consideration. The availability of these data will allow for a better understanding of the therapeutic needs in this area.

Study Overview

• Status: Withdrawn
• Conditions: Coronary Disease
• Intervention / Treatment: Drug: Bivalirudin (thrombin specific anticoagulant)

• Study Type: Observational

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Primary care clinic

Description

Inclusion Criteria :

• Medical condition or disease to be studied: age > 18 years.

• Patients are candidates for a PCI with a planned anticoagulation regime other than unfractionated heparin in monotherapy. Taking into consideration the national and international guidelines for this area and the registered indications of the drugs currently used for this purpose it is predicted that the patients will probably receive one of the following:

  • unfractionated heparin as an intravenous (IV) bolus followed by IV bolus + infusion of a GPI (abciximab, tirofiban or eptifibatide); or
  • bivalirudin as an IV bolus followed by IV infusion, as per the pertinent Summary of Product Characteristics (SPCs).
• Having provided an informed consent (to anonymous data treatment).
• A planned anticoagulation regime means that any candidate patient should be identified on the basis of pre-procedural factors and requested to give his/her consent before the PCI is initiated. Patients receiving bail-out GPI for intraprocedural complications should NOT be considered for the inclusion. However, a pre-included patient could receive a bail-out GPI if deemed necessary.

• The allocation of any individual patient to the category of "high risk" elective PCI will be made independently and autonomously by the caring physician. However, it is recommended to consider the suitability of patients on the basis of these indicative elements:

  • age > 75 years.
  • known diabetes mellitus (type I or type II).
  • known renal insufficiency, i.e. serum creatinine > 1.8 mg or glomerular filtration rate (GFR) > 60 ml/min (calculated with the Cockroft formula).
  • multivessel or complex procedure.
  • planned stent on a bifurcation.
  • planned stent > 6 cm long.
  • PCI on a degenerated venous bypass: in this particular case a distal protection device should always be used.
  • non ST elevation acute coronary syndrome with a PCI planned later than 72 hours after the diagnosis without clinical instability (= "cooled" non ST elevation acute coronary syndrome). This type of patient is considered to be essentially stable and his/her level of risk can be comparable to the risk of patients who are candidates for elective PCI with additional risk factors as listed above.

Exclusion Criteria:

• There will be no specific exclusion criteria other than those listed in the Summary of Product Characteristics of every individual agent.

Study Plan

How is the study designed?

Collaborators and Investigators

• Sponsor: Nycomed
• Investigators: Study Chair: Nycomed Clinical Project Management, Headquarters

Study record dates

Study Major Dates

• Study Start: March 1, 2006
• Study Completion (Anticipated): February 1, 2008

Study Registration Dates

• First Submitted: March 30, 2006
• First Submitted That Met QC Criteria: April 19, 2006
• First Posted (Estimate): April 24, 2006

Study Record Updates

• Last Update Posted (Estimate): May 7, 2012
• Last Update Submitted That Met QC Criteria: May 4, 2012
• Last Verified: May 1, 2012

More Information

Terms related to this study

• Keywords: Patients candidate to a PCI with a planned anticoagulation regime other than unfractionated heparin in monotherapy
• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Coronary Disease; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Protease Inhibitors; Antithrombins; Serine Proteinase Inhibitors; Hemostatics; Coagulants; Thrombin; Bivalirudin; Anticoagulants
• Other Study ID Numbers: BI-006-IT