Myocardial InfarctionPhase 2NCT00060554
A Safety and Efficacy Trial Evaluating the Use of Fondaparinux in Percutaneous Coronary Intervention (PCI)(63133)(WITHDRAWN)
A Phase 2 study testing fondaparinux sodium, heparin and percutaneous coronary intervention (PCI) in people with Myocardial Infarction and Coronary Disease, run by Schering-Plough at 26 sites in 3 countries.
Trial summary
The purpose of this research study is to obtain experience in the use of fondaparinux (Arixtra) as compared to heparin when administered to patients who undergo percutaneous coronary intervention (PCI). Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Myocardial Infarction, Coronary Disease
- What is being tested?
- fondaparinux sodium, heparin and percutaneous coronary intervention (PCI)
- Type of treatment
- Surgery or procedure
- How many people
- 300 participants
- Where
- 26 sitesin 3 countries
- Study dates
- Apr 2003to not given
- Phase
- Phase 2
- 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Scheduled for PCI, including PCI for non-ST elevation acute coronary syndromes (ACS), primary PCI for ST elevation myocardial infarction (MI) or elective PCI (with planned overnight stay in hospital). (Patients undergoing diagnostic heart catherization who are suitable candidates for "ad hoc" PCI are also eligible).
Who cannot join
- Age < 21 years
- Activated Clotting Time (ACT) > 200 seconds immediately prior to PCI
- Use of low molecular weight heparin (LMWH) in the previous 6 hours before PCI
- Currently receiving an oral anticoagulant (OAC) agent with an INR > 1.8
- Thrombolytic therapy for ST elevation MI in the previous 24 hours before PCI
- Active internal bleeding or history of hemorrhagic diathesis
Show all 11Show fewer
- Thrombocytopenia (platelet count < 100 x 10-9/L)
- Pregnant women or women of childbearing potential who are not using an effective method of contraception
- Known allergy to unfractionated heparin, fondaparinux, aspirin or clopidogrel
- Absolute contra-indication to anticoagulation
- Participation in other clinical research studies involving the evaluation of other investigational drugs or devices within 30 days of enrollment or prior participation in this study.
Trial locations and contacts
26 sites in 3 countries.
26 sites in 3 countries
Canada11 sites
Foothills Hospital
Calgary, Alberta, T2N 2T9
University of Alberta Hospital
Edmonton, Alberta, T6G 2R7
QE II Health Sciences Centre, New Halifax Infirmary
Halifax, Nova Scotia, B3H 3A7
HGH-McMaster Clinic
Hamilton, Ontario, L81 2X2
Montreal Heart Institute
Montreal, Quebec, H1T 1C8
Hopital du Sacre-Coeur de Montreal
Montreal, Quebec, H4J 1C5
University of Ottawa Heart Institute
Ottawa, Ontario, K1Y 4W7
Sunnybrook & Women's College Health Sciences Center
Toronto, Ontario, M4N 3M5
St. Michael's Hospital
Toronto, Ontario, M5B 1W8
Toronto General Hospital
Toronto, Ontario, M5G 2C4
Vancouver Hospital & Health Sciences Centre
Vancouver, British Columbia, V5Z 1M9
United States8 sites
University of Michigan, Dept. of Internal Medicine
Ann Arbor, Michigan, 48109
University of Virginia Health System
Charlottesville, Virginia, 22908
University of Chicago - Section of Cardiology
Chicago, Illinois, 60637
Greenville Hospital System
Greenville, South Carolina, 29605
The Methodist Hospital
Houston, Texas, 77030
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
Ocala Research Institute, Inc.
Ocala, Florida, 34480
UMass Memorial Medical Center
Worcester, Massachusetts, 01655
France7 sites
Hopital Jean Minjoz
Besançon, Cedex, 25030
CHU de Caen
Caen, Cedex, 14033
Hopital du Bocage
Dijon, Cedex, 21034
Centre Hospitalier de Lagny-Marne La Vallee
Lagny, Sur Marne, 77405
Hopital Europeen Georges Pompidou
Paris, 75015
Hopital Bichat
Paris, 75018
CHU de Rangueil
Toulouse, Cedex, 31043
About this study
The purpose of this research study is to obtain experience in the use of fondaparinux (Arixtra) as compared to heparin when administered to patients who undergo percutaneous coronary intervention (PCI). PCI is a mechanical procedure used to widen the narrowing in a coronary artery in patients with symptomatic coronary artery disease. Fondaparinux and heparin are drugs that inhibit blood clotting.
- Conditions
- Myocardial Infarction, Coronary Disease
- Being tested
- fondaparinux sodium, heparin, percutaneous coronary intervention (PCI)
- Keywords
- Elective PCI, Heart catherization, Acute coronary syndromes
- Medical subject headings
- Myocardial Infarction, Coronary Disease, Acute Coronary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fondaparinux sodiumDrug
heparinDrug
percutaneous coronary intervention (PCI)Procedure or surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2003 (estimated)
- Study startApr 2003
Why it stopped: Drug sold to Sanofi-Aventis who sold it to GSK; OBS no longer owns study and does not have data.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myocardial InfarctionStudies 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 300 participants
Sponsor and investigators
- Lead sponsor
- Schering-Plough
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00060554
- Sponsor's protocol ID
- 63133 (ASPIRE-Pilot)
- Status last verified
- Nov 2009
- First submitted
- 7 May 2003
- Last updated
- 3 Nov 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Safety and Efficacy Trial Evaluating the Use of Fondaparinux in Percutaneous Coronary Intervention (PCI)(63133)(WITHDRAWN)
- ClinicalTrials.gov ID
- NCT00060554
- Acronym / sponsor ID
- 63133 (ASPIRE-Pilot)
- Conditions
- Myocardial Infarction, Coronary Disease
- Keywords
- Elective PCI, Heart catherization, Acute coronary syndromes
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Drug sold to Sanofi-Aventis who sold it to GSK; OBS no longer owns study and does not have data.
- Enrolment
- 300 participants
- Lead sponsor
- Schering-PloughIndustry (pharma, biotech, devices)
- Study start
- Apr 2003
- First posted
- 8 May 2003 (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.
The purpose of this research study is to obtain experience in the use of fondaparinux (Arixtra) as compared to heparin when administered to patients who undergo percutaneous coronary intervention (PCI). PCI is a mechanical procedure used to widen the narrowing in a coronary artery in patients with symptomatic coronary artery disease. Fondaparinux and heparin are drugs that inhibit blood clotting.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Scheduled for PCI, including PCI for non-ST elevation acute coronary syndromes (ACS), primary PCI for ST elevation myocardial infarction (MI) or elective PCI (with planned overnight stay in hospital). (Patients undergoing diagnostic heart catherization who are suitable candidates for "ad hoc" PCI are also eligible).
Key exclusion criteria (11 listed)
- Age < 21 years
- Activated Clotting Time (ACT) > 200 seconds immediately prior to PCI
- Use of low molecular weight heparin (LMWH) in the previous 6 hours before PCI
- Currently receiving an oral anticoagulant (OAC) agent with an INR > 1.8
- Thrombolytic therapy for ST elevation MI in the previous 24 hours before PCI
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 |
|---|---|---|
| fondaparinux sodium | Drug | – |
| heparin | Drug | – |
| percutaneous coronary intervention (PCI) | Procedure or surgery | – |
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 3 Nov 2009.
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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.
The record lists no contact. Use the official record to reach the sponsor.
26 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing fondaparinux sodium, heparin and percutaneous coronary intervention (PCI) in people with Myocardial Infarction and Coronary Disease, run by Schering-Plough at 26 sites in 3 countries.
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 1 inclusion and 11 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 3 Nov 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 26 sites in Canada, United States, France. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 3 Nov 2009.