Coronary DiseaseNCT00317343
RIAPRE - Non-interventional Registry of Anticoagulation Treatment (BI-006-IT)
An observational study of Coronary Disease, run by Nycomed.
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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Coronary Disease
- What is being tested?
- Bivalirudin (thrombin specific anticoagulant)
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Mar 2006to Feb 2008
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Primary care clinic
Who may be able to join
- 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.
Show all 15Show fewer
- 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.
Who cannot join
- There will be no specific exclusion criteria other than those listed in the Summary of Product Characteristics of every individual agent.
About this study
Official title: 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.
- Conditions
- Coronary Disease
- Being tested
- Bivalirudin (thrombin specific anticoagulant)
- Keywords
- Patients candidate to a PCI with a planned anticoagulation regime other than unfractionated heparin in monotherapy
- Medical subject headings
- Coronary Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bivalirudin (thrombin specific anticoagulant)Drug
Percutaneous Coronary Intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2006 (estimated)
- Study startMar 2006
- Study completionFeb 2008 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nycomed
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Nycomed Clinical Project Management, Study chair, Headquarters
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00317343
- Sponsor's protocol ID
- BI-006-IT
- Status last verified
- May 2012
- First submitted
- 30 Mar 2006
- Last updated
- 7 May 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- RIAPRE - A Non-interventional Registry on the Anticoagulation Treatment in High Risk Elective Percutaneous Coronary Interventions
- ClinicalTrials.gov ID
- NCT00317343
- Acronym / sponsor ID
- BI-006-IT
- Conditions
- Coronary Disease
- Keywords
- Patients candidate to a PCI with a planned anticoagulation regime other than unfractionated heparin in monotherapy
- Study type
- Observational
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- NycomedIndustry (pharma, biotech, devices)
- Study start
- Mar 2006
- Study completion
- Feb 2008 (estimated)
- First posted
- 24 Apr 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Primary care clinic
Key inclusion criteria (15 listed)
- 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:
- 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:
Key exclusion criteria (1 listed)
- There will be no specific exclusion criteria other than those listed in the Summary of Product Characteristics of every individual agent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bivalirudin (thrombin specific anticoagulant)Percutaneous Coronary Intervention | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2012.
Related trials for Coronary Disease
Not yet recruiting
Effect of Stress Ball Use During Femoral Arterial Sheath Removal After Coronary Angiography
Femoral Arterial Sheath Removal, Stress Ball
Active, not recruiting
Shockwave™ vs Surgical Endarterectomy for Calcified Severe Common Femoral Artery Stenosis: Comparison of Efficacy, Safety and Long-Term Outcomes
Common Femoral Artery Stenosis, Calcification; Heart
RecruitingObservational study
AI-powered ECG Analysis Using Willem™ Software in High-risk Cardiac Patients (WILLEM)
Cardiomyopathies, Cardiac Arrest
RecruitingPhase 4
The Effects of Ferric Derisomaltose in Patients With Acute Heart Failure and Iron Deficiency on Exercise Capacity and Quality of Life(COREVIVE-HFrEF)
Heart Failure With Reduced Ejection Fraction, Iron Deficiency
Recruiting
Trial of the F2 Filter and Delivery System for Embolic Protection During TAVR
Aortic Stenosis Treated With TAVI, Aortic Diseases
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nycomed Clinical Project Management study chair
Headquarters
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Disease, run by Nycomed.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 7 May 2012. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2012.