Angioplasty, Transluminal, Percutaneous CoronaryPhase 2SEPIA-PCINCT00133731
The SEPIA-PCI Trial: Otamixaban in Comparison to Heparin in Subjects Undergoing Non-Urgent Percutaneous Coronary Intervention
A Phase 2 study testing Otamixaban (XRP0673), Unfractionated Heparin and Percutaneous Coronary Intervention in people with Angioplasty, Transluminal, Percutaneous Coronary, run by Sanofi at 89 sites in 10 countries.
Trial summary
The objective of this dose-ranging study is to determine the effects of several intravenous (IV) regimens of otamixaban on pharmacodynamic markers (including markers of thrombosis and coagulation markers), safety/tolerability, clinical efficacy and pharmacokinetics. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Angioplasty, Transluminal, Percutaneous Coronary
- What is being tested?
- Otamixaban (XRP0673), Unfractionated Heparin and Percutaneous Coronary Intervention
- Type of treatment
- Surgery or procedure
- How many people
- 947 participants
- Where
- 89 sitesin 10 countries
- Study dates
- Sep 2004to Oct 2005
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years of age or older
- Due to undergo non-urgent percutaneous coronary intervention (PCI)
- Planned treatment with aspirin and clopidogrel
Who cannot join
- Recent acute coronary syndrome
- Patients at risk for, or with prior recent, bleeding
- Patients have received recent prior treatment with an anticoagulant
- Creatinine clearance > 30 ml/min
Trial locations and contacts
89 sites in 10 countries.
89 sites in 10 countries
United States37 sites
Amarillo Heart Clinical Research Institute Inc
Amarillo, Texas, 79106
Cardiac Disease Specialists
Atlanta, Georgia, 30309
Emory University Hospital
Atlanta, Georgia, 30322
Florida Cardiovascular Research
Atlantis, Florida, 33462
Rush University Medical Center
Chicago, Illinois, 60612
The Lindner Clinical Trial Center
Cincinnati, Ohio, 45219
The Cleveland Clinic Foundation
Cleveland, Ohio, 44195
Columbia Heart Clinic
Columbia, South Carolina, 29203
Geisinger Clinic
Danville, Pennsylvania, 17822-2160
Iowa Heart Center, PC
Des Moines, Iowa, 50314
LeBauer Cardiovascular Research Foundation
Greensboro, North Carolina, 27401
Milton S. Hershey Medical Center
Hershey, Pennsylvania, 17033
MEDVAMC
Houston, Texas, 77030
The Care Group, LLC
Indianapolis, Indiana, 46290
Midwest Heart Foundation
Lombard, Illinois, 60148
Los Angeles Cardiology Associates
Los Angeles, California, 90017
Loyola University Medical Center
Maywood, Illinois, 61053
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
Minneapolis Heart Institute Foundation
Minneapolis, Minnesota, 55407
Newark Beth Israel Medical Center
Newark, New Jersey, 07112
Ocala Research Institute, Inc
Ocala, Florida, 34480
University of Oklahoma Health Science Center
Oklahoma City, Oklahoma, 73104
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73104
Plaza Medical Group, PC
Oklahoma City, Oklahoma, 73112
Central Florida Cardiology Group, PA
Orlando, Florida, 32803
Cardiology Associates, PA
Panama City, Florida, 32401
Heart Care Midwest
Peoria, Illinois, 61603
University of Pennsylvania Health System
Philadelphia, Pennsylvania, 19104
Wake Heart Associates
Raleigh, North Carolina, 27610
Virginia Commonwealth University
Richmond, Virginia, 23298-0036
Audie Murphy VA Medical Center
San Antonio, Texas, 78229
Anil V. Shah, MD
Santa Ana, California, 92704
Heart Specialists of Sarasota
Sarasota, Florida, 34239
Prairie Cardiovascular Consultants, Ltd
Springfield, Illinois, 62702
George Washington University Medical Faculty Associates
Washington D.C., District of Columbia, 20037
Kansas Cardiology Associates
Wichita, Kansas, 67214
UMass Memorial Medical Center
Worcester, Massachusetts, 01605-0002
Germany17 sites
Medisch Centrum Alkmarr
Alkmaar, 1815 JD
Kerckhoff-Klinik GmbH
Bad Nauheim, D-61231
Universitatmedizin Berlin
Berlin, D-12200
Vivantes Klinikum Neukolln
Berlin, D-12351
Virchow-Klinikum, Universtatsmedizin Berlin
Berlin, D-13353
Klinikum der Universitat au Koln
Cologne, D-50924
Krankanhaus Duren gem.GmbH
Düren, 52351
Klinikum der Johann Wolfgang Goethe-Universitat
Frankfurt, D-60590
Universitatsklinikum Freiburg
Freiburg im Breisgau, D-79106
Gamelinschalftspraxis
Hamburg, 22763
Universitatsklinikum Hamburg - Eppendorf
Hamburg, D-20246
Klinikum der Friedrich-Schiller-Universitat Jena
Jena, 07740
Universitatsklinikum Schleswig-Holstein
Lübeck, D-23538
Johannes Gutenberg Universitat Mainz
Mainz, 55131
Klinik der Universitat Munchen-Grobhadern
München, D-81377
Klinikum Schwalmstadt der Schwalm-Eder-Kliniken
Schwalmstadt, D-34613
Segeberger Kliniken GmbH
Segeberg, D-23795
Canada9 sites
Foothills Medical Center
Calgary, Alberta, T2N 219
Institut de Cardiologie de Montreal
Montreal, Quebec, H1T 1C8
Cardiac Catheterization Laboratories of the CHUM
Montreal, Quebec, H2L 4MI
CHUM - Hopital St-Luc
Montreal, Quebec, H2X 3J4
Hopital du Sacre-Coeur de Montreal
Montreal, Quebec, H4J IC5
Southlake Regional Health Centre
Newmarket, Ontario, L3Y 2P9
Centre Hospitalier Universitaire de Sherbrooke
Sherbrooke, Quebec, J1H 5N4
Sunnybrook and Women's College Health Sciences Centre
Toronto, Ontario, M4N 3M5
St. Boniface General Hospital
Winnipeg, Manitoba, R2H 2A6
Spain6 sites
Hospital San Juan de Alicante
Alicante, 03550
Hospital Clinic de Barcelona
Barcelona, 08036
Hospital Universitari Bellvitge
Barcelona, 08907
Hospital Clinico San Carlos
Madrid, 28040
Hospital Gregorio Maranon
Madrid, 28807
Hospital Virgen de la Victoria
Málaga, 29010
France5 sites
Center Hospitalier Universitaire Jean-Minjoz
Besançon, 25030
Hopital Cardiologique Louis Pradel
Bron, Cedex, 69677
Institut Hospitalier Jacques Cartier
Massy, Cedex, 91949
Clinique Les Franciscaines
Nîmes, 30000
Institut de Cardiologie
Paris, 75013
Netherlands5 sites
Amphia Hospital
Breda, 4836 AE
Catherine Hospital
Eindhoven, 5823 EJ
St Antonius Hospital
Nieuwegein, 3435 CM
Medisch Centrum Rijnmond-Zuid
Rotterdam, 3075 EA
Isala Klinleken, Hospital De Weezenlanden
Zwolle, 8011 JW
Czechia4 sites
University Hospital St Anna
Brno, 656 91
University Hospital Hradec Kralove
Hradec Králové, 408
General University Hospital
Prague, 2, 120 08
University Hospital Motol
Prague, 5, 150 06
Belgium2 sites
Cliniques Universitaires Saint-Luc
Brussels, 1200
UZ Gasthuisberg
Leuven, 3000
Slovakia2 sites
Middle Slovak Institute of Cardiovascular Diseases
Banská Bystrica
Slovak Institute of Cardiovascular Diseases
Bratislava
South Africa2 sites
Milpark Hospital
Johannesburg
Kuils River Private Hospital
Kuils River, 7580
About this study
Official title: A Multinational, Randomized, Double-Blind, Double-Dummy, Exploratory, Parallel Group, Dose-Ranging Phase II Study to Evaluate Pharmacodynamics, Safety and Tolerability, and Pharmacokinetics of Several Intravenous Regimens of Factor Xa Inhibitor Otamixaban (XRP0673), in Comparison to Intravenous Unfractionated Heparin, in Subjects Undergoing Non-Urgent Percutaneous Coronary Intervention
The objective of this dose-ranging study is to determine the effects of several intravenous (IV) regimens of otamixaban on pharmacodynamic markers (including markers of thrombosis and coagulation markers), safety/tolerability, clinical efficacy and pharmacokinetics.
- Being tested
- Otamixaban (XRP0673), Unfractionated Heparin, Percutaneous Coronary Intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Otamixaban (XRP0673)Drug
Unfractionated HeparinDrug
Percutaneous Coronary InterventionProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Death, myocardial infarction, and urgent and non-urgent target vessel revascularization
Secondary outcomes (1)
Bleeding events
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2005 (estimated)
- Study startSep 2004
- Study completionOct 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Angioplasty, Transluminal, Percutaneous CoronaryStudies of the same condition, open and under way.
- More trials run by SanofiThe sponsor's other registered studies.
- 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
- 947 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- ICD CSD, Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00133731
- Sponsor's protocol ID
- DRI6199
- Other IDs
- XRP0673
- Acronym
- SEPIA-PCI
- Status last verified
- Jun 2008
- First submitted
- 23 Aug 2005
- Last updated
- 2 Jul 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multinational, Randomized, Double-Blind, Double-Dummy, Exploratory, Parallel Group, Dose-Ranging Phase II Study to Evaluate Pharmacodynamics, Safety and Tolerability, and Pharmacokinetics of Several Intravenous Regimens of Factor Xa Inhibitor Otamixaban (XRP0673), in Comparison to Intravenous Unfractionated Heparin, in Subjects Undergoing Non-Urgent Percutaneous Coronary Intervention
- ClinicalTrials.gov ID
- NCT00133731
- Acronym / sponsor ID
- SEPIA-PCI / DRI6199
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 947 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- Sep 2004
- Study completion
- Oct 2005 (actual)
- First posted
- 24 Aug 2005 (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 objective of this dose-ranging study is to determine the effects of several intravenous (IV) regimens of otamixaban on pharmacodynamic markers (including markers of thrombosis and coagulation markers), safety/tolerability, clinical efficacy and pharmacokinetics.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 18 years of age or older
- Due to undergo non-urgent percutaneous coronary intervention (PCI)
- Planned treatment with aspirin and clopidogrel
Key exclusion criteria (4 listed)
- Recent acute coronary syndrome
- Patients at risk for, or with prior recent, bleeding
- Patients have received recent prior treatment with an anticoagulant
- Creatinine clearance > 30 ml/min
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 |
|---|---|---|
| Otamixaban (XRP0673) | Drug | – |
| Unfractionated Heparin | Drug | – |
| Percutaneous Coronary Intervention | Procedure or surgery | – |
Primary outcome
Death, myocardial infarction, and urgent and non-urgent target vessel revascularization
1 secondary outcome
Bleeding events
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2008.
- Related InfoLink provided by the sponsor.
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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.
ICD CSD study director
Sanofi
89 sites in 10 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Otamixaban (XRP0673), Unfractionated Heparin and Percutaneous Coronary Intervention in people with Angioplasty, Transluminal, Percutaneous Coronary, run by Sanofi at 89 sites in 10 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 3 inclusion and 4 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: finished, as of the sponsor's last update on 2 Jul 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 89 sites in United States, Germany, Canada, Spain, France and 5 more countries. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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.
What does the primary outcome measure?
Death, myocardial infarction, and urgent and non-urgent target vessel revascularization. It is what the study was designed to measure, not a finding.
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 2 Jul 2008.