Current partner codePEPTIDESDE
NCT00317343·Not applicable·OBSERVATIONAL

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

Status

Withdrawn

Phase

Not applicable

Enrollment

0

Locations

0

Results

Not posted

Publications

0

Study summary

What the protocol is testing.

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.

Interventions

Treatment arms and agents.

DRUG

Bivalirudin (thrombin specific anticoagulant)

Percutaneous Coronary Intervention

Timeline

From registration to results.

  1. First posted

    Apr 24, 2006

  2. Study start

    Mar 2006

  3. Primary completion

    Not reported

  4. Study completion

    Feb 2008

  5. Results posted

    Not reported

  6. Registry updated

    May 7, 2012

Outcomes

What the study measures.

Primary outcomes

Not reported in the indexed record.

Secondary outcomes

Not reported in the indexed record.

Eligibility

Who can take part.

Minimum age
18 Years
Maximum age
90 Years
Sex
ALL
Healthy volunteers
No

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 locations

0 registered sites.

No country data reported. Showing up to 24 locations stored in the fast local snapshot.

No study locations reported.

Publications

Results and literature.

No PMID-linked publications were present in this registry snapshot.

Primary links

Continue at the source.

Related trials

More studies on Bivalirudin.

Related PeptideStat pages

Put the record in context.

Research pages describe evidence. Vendor pages, where available, describe independently tracked research-product listings and are not clinical recommendations.