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

This study has been withdrawn prior to enrollment.
Sponsor:
Information provided by:
Nycomed
ClinicalTrials.gov Identifier:
NCT00317343
First received: March 30, 2006
Last updated: May 4, 2012
Last verified: May 2012
  Purpose

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.


Condition Intervention Phase
Coronary Disease
Drug: Bivalirudin (thrombin specific anticoagulant)
Phase 4

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: RIAPRE - A Non-interventional Registry on the Anticoagulation Treatment in High Risk Elective Percutaneous Coronary Interventions

Resource links provided by NLM:


Further study details as provided by Nycomed:

Enrollment: 0
Study Start Date: March 2006
Estimated Study Completion Date: February 2008
Intervention Details:
    Drug: Bivalirudin (thrombin specific anticoagulant)
    Percutaneous Coronary Intervention
  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Primary care clinic

Criteria

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.
  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 ClinicalTrials.gov identifier: NCT00317343

Sponsors and Collaborators
Nycomed
Investigators
Study Chair: Nycomed Clinical Project Management Headquarters
  More Information

No publications provided

Responsible Party: Nycomed
ClinicalTrials.gov Identifier: NCT00317343     History of Changes
Other Study ID Numbers: BI-006-IT
Study First Received: March 30, 2006
Last Updated: May 4, 2012
Health Authority: Italy: Ministry of Health

Keywords provided by Nycomed:
Patients candidate to a PCI with a planned anticoagulation regime other than unfractionated heparin in monotherapy

Additional relevant MeSH terms:
Coronary Artery Disease
Coronary Disease
Arterial Occlusive Diseases
Arteriosclerosis
Cardiovascular Diseases
Heart Diseases
Myocardial Ischemia
Vascular Diseases
Anticoagulants
Hematologic Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014