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

Coronary Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00317343
• Other study ID #: BI-006-IT
• Status: Withdrawn
• Phase: Phase 4
• First received: March 30, 2006
• Last updated: May 4, 2012
• Start date: March 2006
• Est. completion date: February 2008

Study information

• Verified date: May 2012
• Source: Nycomed
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ministry of Health
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: February 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

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 Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease

Intervention

Drug:
• Bivalirudin (thrombin specific anticoagulant)
Percutaneous Coronary Intervention

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Nycomed