StrokePhase 3NCT00432796
PERIOP 2 - A Safety and Effectiveness of LMWH vs Placebo Bridging Therapy for Patients on Long Term Warfarin Requiring Temporary Interruption of Warfarin.
A Phase 3 study testing Dalteparin in people with Stroke, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 8 sites in 2 countries.
Trial summary
The purpose of the study is to determine the effectiveness and safety of LMWH postoperative bridging therapy (standard of care) versus postoperative placebo bridging therapy (experimental arm)for patients with mechanical heart valves or atrial fibrillation or atrial flutter who are at high risk for stroke when… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke
- What is being tested?
- Dalteparin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,473 participants
- Where
- 8 sitesin 2 countries
- Study dates
- Dec 2006to Dec 2020
- Phase
- Phase 3
- 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
- Informed consent,
- Patients aged >18
- Patients with prosthetic(mechanical) heart valve
- Patients with atrial fibrillation or atrial flutter and a major risk factor (previous TIA or stroke, high blood pressure, diabetes, aged >75, moderate/severe left ventricle dysfunction)
- Who are receiving long-term oral anticoagulation and require elective non-cardiac surgery or an invasive procedure with reversal of their anticoagulant therapy.
Who cannot join
- Evidence of active bleeding within last 30 days prior to stopping warfarin.
- Platelet count <100 x 109/L.
- Spinal or neurosurgery.
- Life expectancy less than 3 months.
- Calculated creatinine clearance <30 ml/min
- Patients requiring cardiac surgery.
- Multiple prosthetic(mechanical) valves or Starr-Edwards valve or prosthetic(mechanical) valve with a history of stroke or TIA
- History of heparin induced thrombocytopenia (HIT)
Trial locations and contacts
8 sites in 2 countries.
8 sites in 2 countries
Canada6 sites
QE II Health Sciences Centre
Halifax, Nova Scotia, B3H 2Y9
Hamilton Health Sciences Corporation-General Hospital
Hamilton, Ontario, L8L 2X2
Hamilton Health Sciences Corporation-McMaster Site
Hamilton, Ontario, L8N 3Z5
Hamilton Health Sciences Corporation-Henderson Site
Hamilton, Ontario, L8V 1C3
SMBD Jewish General Hospital
Montreal, Quebec, H3T 1E2
Ottawa Hospital-General Campus
Ottawa, Ontario, K1H 8L6
India2 sites
Care Hospital
Hyderabad, Nampally, 500001
Sir Ganga Ram Hospital
New Delhi, 110060
About this study
Official title: A Double Blind Randomized Control Trial of Post-Operative Low Molecular Weight Heparin Bridging Therapy Versus Placebo Bridging Therapy for Patients Who Are at High Risk for Arterial Thromboembolism (PERIOP 2)
The purpose of the study is to determine the effectiveness and safety of LMWH postoperative bridging therapy (standard of care) versus postoperative placebo bridging therapy (experimental arm)for patients with mechanical heart valves or atrial fibrillation or atrial flutter who are at high risk for stroke when warfarin is temporarily interrupted for a procedure.
Read the detailed description
There are a growing number of patients who receive long-term warfarin therapy for the prevention of arterial thromboembolism. The current approach to the perioperative management of anticoagulation (i.e. "bridging therapy") with low molecular weight heparin (LMWH) is not standardized and has not been assessed by adequate randomized studies. Most clinicians, however, recommend bridging therapy.
We have recently completed a multicentre single arm pilot study of LMWH bridging therapy. This study in 10 centres accrued 224 patients in 10 months. In the pilot study the postoperative thromboembolic event rate was 3.1% and 75% of these occurred in patients who had anticoagulation held due to bleeding.
Design:A prospective multicentre randomized double-blind controlled trial. Patients: Consecutive eligible and consenting patients from 11 teaching hospitals in Canada. A total of 1773 patients with prosthetic heart valves receiving long-term oral anticoagulation with warfarin or patients with atrial fibrillation/flutter and a major risk factor who require elective non-cardiac surgery or invasive procedure necessitating reversal of their oral anticoagulant therapy.
Treatment Schedule: Consent will be obtained preoperatively but randomization will be performed postoperatively after confirming eligibility.
Preoperative period: In all participants, warfarin therapy will be discontinued five days prior to the procedure. Dalteparin, a LMWH, will be administered at 200 IU/kg sc early in the morning for the three days prior to, but not including the day of, the procedure except on the day prior to surgery the dose will be 100 I.U./kg given 24 hours preoperatively. Warfarin will be resumed the evening of the procedure.
Postoperative period: Dalteparin or placebo will be administered daily (starting the morning after the procedure), provided surgical hemostasis is achieved, and will be continued for at least four days and until the INR is>2.0. Patients considered at high risk for a postoperative major bleed will be given dalteparin or placebo at a dose of 5,000 IU sc daily. Patients who undergo procedures that are considered low risk for bleeding complications will resume dalteparin or placebo at 200 IU/Kg s.c. daily.
Outcomes:The primary outcome will be the frequency of episodes of major thromboembolism over a 90-day follow-up period following the time of randomization. Secondary outcomes will include major bleeding and overall survival.
Relevance: To bridge or not to bridge, is a common clinical question, without randomized trial evidence to guide clinicians. This RCT will answer whether post-operative bridging reduces risk of thromboembolism or causes harm.
- Conditions
- Stroke
- Being tested
- Dalteparin, Placebo
- Keywords
- Anticoagulation, Prosthetic heart valves, Atrial fibrillation, Bridging Therapy, Thromboembolism, Warfarin, Low Molecular Weight Heparin
- Medical subject headings
- Stroke, Atrial Fibrillation, Thromboembolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DalteparinDrug
Also called Fragmin
5,000 iu or 200 iu/kg depending on the type of surgery injection will be given subcutaneously, once a day for a minimum of 4 days or until the INR is 2.0
PlaceboOther
patients will be randomized post-operative to receive either active treatment or placebo.
the placebo will be given as a subcutaneous injection once a day. the amount of the placebo will be equivalent to the active treatment depending on the type of surgery.
ie. 5,000 iu or 200 iu/kg
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | patients are randomized post-operative to receive either active treatment or placebo.
Active treatment is Dalteparin injectable. Patients randomized to active treatment will receive Dalteparin 5,000 iu or 200 iu/kg once daily depending on the type of surgery they have had. Receives: Drug: Dalteparin |
| 2 | Experimental | patients will be randomized post-operative to receive either active treatment or placebo Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
major thromboembolism
Measured: 90 days from randomization
Secondary outcomes (5)
major bleeding
Measured: 90 days from randomization
minor bleeding
Measured: 90 days from randomization
a composite of major bleeding and major thromboembolic events
Measured: 90 days from randomization
minor thromboembolic events
Measured: 90 days from randomization
overall survival.
Measured: 90 days from randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2007 (estimated)
- Study startDec 2006
- Primary completionMar 2019
- Study completionDec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (46)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sThe 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 1,473 participants (actual)
Sponsor and investigators
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR), Pfizer
- Responsible party
- Principal investigator, Michael Kovacs, London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Investigators
- Michael J Kovacs, MD, FRCPC, Principal investigator, University of Western Ontario, Canada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00432796
- Sponsor's protocol ID
- R-06-267
- Other IDs
- NRA6300019
- Status last verified
- Feb 2020
- First submitted
- 7 Feb 2007
- Last updated
- 19 Feb 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Tu JV, Gong Y. Trends in treatment and outcomes for acute stroke patients in Ontario, 1992-1998. Arch Intern Med. 2003 Feb 10;163(3):293-7. doi: 10.1001/archinte.163.3.293.
PubMed 12578509Kearon C, Hirsh J. Management of anticoagulation before and after elective surgery. N Engl J Med. 1997 May 22;336(21):1506-11. doi: 10.1056/NEJM199705223362107. No abstract available.
PubMed 9154771Vongpatanasin W, Hillis LD, Lange RA. Prosthetic heart valves. N Engl J Med. 1996 Aug 8;335(6):407-16. doi: 10.1056/NEJM199608083350607. No abstract available.
PubMed 8676934Cannegieter SC, Rosendaal FR, Briet E. Thromboembolic and bleeding complications in patients with mechanical heart valve prostheses. Circulation. 1994 Feb;89(2):635-41. doi: 10.1161/01.cir.89.2.635.
PubMed 8313552White RH, McKittrick T, Hutchinson R, Twitchell J. Temporary discontinuation of warfarin therapy: changes in the international normalized ratio. Ann Intern Med. 1995 Jan 1;122(1):40-2. doi: 10.7326/0003-4819-122-1-199501010-00006.
PubMed 7985894Kovacs MJ, Rodger M, Anderson DR, Morrow B, Kells G, Kovacs J, Boyle E, Wells PS. Comparison of 10-mg and 5-mg warfarin initiation nomograms together with low-molecular-weight heparin for outpatient treatment of acute venous thromboembolism. A randomized, double-blind, controlled trial. Ann Intern Med. 2003 May 6;138(9):714-9. doi: 10.7326/0003-4819-138-9-200305060-00007.
PubMed 12729425Madura JA, Rookstool M, Wease G. The management of patients on chronic Coumadin therapy undergoing subsequent surgical procedures. Am Surg. 1994 Jul;60(7):542-6; discussion 546-7.
PubMed 8010570Eckman MH, Beshansky JR, Durand-Zaleski I, Levine HJ, Pauker SG. Anticoagulation for noncardiac procedures in patients with prosthetic heart valves. Does low risk mean high cost? JAMA. 1990 Mar 16;263(11):1513-21.
PubMed 2106590Katholi RE, Nolan SP, McGuire LB. The management of anticoagulation during noncardiac operations in patients with prosthetic heart valves. A prospective study. Am Heart J. 1978 Aug;96(2):163-5. doi: 10.1016/0002-8703(78)90080-7.
PubMed 676976Stein PD, Alpert JS, Copeland J, Dalen JE, Goldman S, Turpie AG. Antithrombotic therapy in patients with mechanical and biological prosthetic heart valves. Chest. 1995 Oct;108(4 Suppl):371S-379S. doi: 10.1378/chest.108.4_supplement.371s. No abstract available.
PubMed 7555190Douketis JD, Crowther MA, Cherian SS, Kearon CB. Physician preferences for perioperative anticoagulation in patients with a mechanical heart valve who are undergoing elective noncardiac surgery. Chest. 1999 Nov;116(5):1240-6. doi: 10.1378/chest.116.5.1240.
PubMed 10559081Dunn AS, Turpie AG. Perioperative management of patients receiving oral anticoagulants: a systematic review. Arch Intern Med. 2003 Apr 28;163(8):901-8. doi: 10.1001/archinte.163.8.901.
PubMed 12719198Douketis JD, Johnson JA, Turpie AG. Low-molecular-weight heparin as bridging anticoagulation during interruption of warfarin: assessment of a standardized periprocedural anticoagulation regimen. Arch Intern Med. 2004 Jun 28;164(12):1319-26. doi: 10.1001/archinte.164.12.1319.
PubMed 15226166Spandorfer JM, Lynch S, Weitz HH, Fertel S, Merli GJ. Use of enoxaparin for the chronically anticoagulated patient before and after procedures. Am J Cardiol. 1999 Aug 15;84(4):478-80, A10. doi: 10.1016/s0002-9149(99)00341-0.
PubMed 10468095Kovacs MJ, Kearon C, Rodger M, Anderson DR, Turpie AG, Bates SM, Desjardins L, Douketis J, Kahn SR, Solymoss S, Wells PS. Single-arm study of bridging therapy with low-molecular-weight heparin for patients at risk of arterial embolism who require temporary interruption of warfarin. Circulation. 2004 Sep 21;110(12):1658-63. doi: 10.1161/01.CIR.0000142859.77578.C9. Epub 2004 Sep 13.
PubMed 15364803
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double Blind Randomized Control Trial of Post-Operative Low Molecular Weight Heparin Bridging Therapy Versus Placebo Bridging Therapy for Patients Who Are at High Risk for Arterial Thromboembolism (PERIOP 2)
- ClinicalTrials.gov ID
- NCT00432796
- Acronym / sponsor ID
- R-06-267
- Conditions
- Stroke
- Keywords
- Anticoagulation, Prosthetic heart valves, Atrial fibrillation, Bridging Therapy, Thromboembolism, Warfarin, Low Molecular Weight Heparin
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,473 participants (actual)
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR), Pfizer
- Study start
- Dec 2006
- Primary completion
- Mar 2019 (actual)
- Study completion
- Dec 2020 (estimated)
- First posted
- 8 Feb 2007 (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 the study is to determine the effectiveness and safety of LMWH postoperative bridging therapy (standard of care) versus postoperative placebo bridging therapy (experimental arm)for patients with mechanical heart valves or atrial fibrillation or atrial flutter who are at high risk for stroke when warfarin is temporarily interrupted for a procedure.
Detailed description
There are a growing number of patients who receive long-term warfarin therapy for the prevention of arterial thromboembolism. The current approach to the perioperative management of anticoagulation (i.e. "bridging therapy") with low molecular weight heparin (LMWH) is not standardized and has not been assessed by adequate randomized studies. Most clinicians, however, recommend bridging therapy.
We have recently completed a multicentre single arm pilot study of LMWH bridging therapy. This study in 10 centres accrued 224 patients in 10 months. In the pilot study the postoperative thromboembolic event rate was 3.1% and 75% of these occurred in patients who had anticoagulation held due to bleeding.
Design:A prospective multicentre randomized double-blind controlled trial. Patients: Consecutive eligible and consenting patients from 11 teaching hospitals in Canada. A total of 1773 patients with prosthetic heart valves receiving long-term oral anticoagulation with warfarin or patients with atrial fibrillation/flutter and a major risk factor who require elective non-cardiac surgery or invasive procedure necessitating reversal of their oral anticoagulant therapy.
Treatment Schedule: Consent will be obtained preoperatively but randomization will be performed postoperatively after confirming eligibility.
Preoperative period: In all participants, warfarin therapy will be discontinued five days prior to the procedure. Dalteparin, a LMWH, will be administered at 200 IU/kg sc early in the morning for the three days prior to, but not including the day of, the procedure except on the day prior to surgery the dose will be 100 I.U./kg given 24 hours preoperatively. Warfarin will be resumed the evening of the procedure.
Postoperative period: Dalteparin or placebo will be administered daily (starting the morning after the procedure), provided surgical hemostasis is achieved, and will be continued for at least four days and until the INR is>2.0. Patients considered at high risk for a postoperative major bleed will be given dalteparin or placebo at a dose of 5,000 IU sc daily. Patients who undergo procedures that are considered low risk for bleeding complications will resume dalteparin or placebo at 200 IU/Kg s.c. daily.
Outcomes:The primary outcome will be the frequency of episodes of major thromboembolism over a 90-day follow-up period following the time of randomization. Secondary outcomes will include major bleeding and overall survival.
Relevance: To bridge or not to bridge, is a common clinical question, without randomized trial evidence to guide clinicians. This RCT will answer whether post-operative bridging reduces risk of thromboembolism or causes harm.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: Dalteparinpatients are randomized post-operative to receive either active treatment or placebo. Active treatment is Dalteparin injectable. Patients randomized to active treatment will receive Dalteparin 5,000 iu or 200 iu/kg once daily depending on the type of surgery they have had. |
| 2 | Experimental | Other: Placebopatients will be randomized post-operative to receive either active treatment or placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Informed consent,
- Patients aged >18
- Patients with prosthetic(mechanical) heart valve
- Patients with atrial fibrillation or atrial flutter and a major risk factor (previous TIA or stroke, high blood pressure, diabetes, aged >75, moderate/severe left ventricle dysfunction)
- Who are receiving long-term oral anticoagulation and require elective non-cardiac surgery or an invasive procedure with reversal of their anticoagulant therapy.
Key exclusion criteria (8 listed)
- Evidence of active bleeding within last 30 days prior to stopping warfarin.
- Platelet count <100 x 109/L.
- Spinal or neurosurgery.
- Life expectancy less than 3 months.
- Calculated 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 |
|---|---|---|
| DalteparinAlso: Fragmin5,000 iu or 200 iu/kg depending on the type of surgery injection will be given subcutaneously, once a day for a minimum of 4 days or until the INR is 2.0 | Drug | 1 |
| Placebopatients will be randomized post-operative to receive either active treatment or placebo. the placebo will be given as a subcutaneous injection once a day. the amount of the placebo will be equivalent to the active treatment depending on the type of surgery. ie. 5,000 iu or 200 iu/kg | Other | 2 |
Primary outcome
major thromboembolism
Time frame: 90 days from randomization
5 secondary outcomes
major bleeding
Time frame: 90 days from randomization
minor bleeding
Time frame: 90 days from randomization
a composite of major bleeding and major thromboembolic events
Time frame: 90 days from randomization
minor thromboembolic events
Time frame: 90 days from randomization
overall survival.
Time frame: 90 days from randomization
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2020.
- Background: PubMed 12578509Tu JV, Gong Y. Trends in treatment and outcomes for acute stroke patients in Ontario, 1992-1998. Arch Intern Med. 2003 Feb 10;163(3):293-7. doi: 10.1001/archinte.163.3.293.
- Background: PubMed 9154771Kearon C, Hirsh J. Management of anticoagulation before and after elective surgery. N Engl J Med. 1997 May 22;336(21):1506-11. doi: 10.1056/NEJM199705223362107. No abstract available.
- Background: PubMed 8676934Vongpatanasin W, Hillis LD, Lange RA. Prosthetic heart valves. N Engl J Med. 1996 Aug 8;335(6):407-16. doi: 10.1056/NEJM199608083350607. No abstract available.
- Background: PubMed 8313552Cannegieter SC, Rosendaal FR, Briet E. Thromboembolic and bleeding complications in patients with mechanical heart valve prostheses. Circulation. 1994 Feb;89(2):635-41. doi: 10.1161/01.cir.89.2.635.
- Background: PubMed 7985894White RH, McKittrick T, Hutchinson R, Twitchell J. Temporary discontinuation of warfarin therapy: changes in the international normalized ratio. Ann Intern Med. 1995 Jan 1;122(1):40-2. doi: 10.7326/0003-4819-122-1-199501010-00006.
- Background: PubMed 12729425Kovacs MJ, Rodger M, Anderson DR, Morrow B, Kells G, Kovacs J, Boyle E, Wells PS. Comparison of 10-mg and 5-mg warfarin initiation nomograms together with low-molecular-weight heparin for outpatient treatment of acute venous thromboembolism. A randomized, double-blind, controlled trial. Ann Intern Med. 2003 May 6;138(9):714-9. doi: 10.7326/0003-4819-138-9-200305060-00007.
- Background: PubMed 8010570Madura JA, Rookstool M, Wease G. The management of patients on chronic Coumadin therapy undergoing subsequent surgical procedures. Am Surg. 1994 Jul;60(7):542-6; discussion 546-7.
- Background: PubMed 2106590Eckman MH, Beshansky JR, Durand-Zaleski I, Levine HJ, Pauker SG. Anticoagulation for noncardiac procedures in patients with prosthetic heart valves. Does low risk mean high cost? JAMA. 1990 Mar 16;263(11):1513-21.
- Background: PubMed 676976Katholi RE, Nolan SP, McGuire LB. The management of anticoagulation during noncardiac operations in patients with prosthetic heart valves. A prospective study. Am Heart J. 1978 Aug;96(2):163-5. doi: 10.1016/0002-8703(78)90080-7.
- Background: PubMed 7555190Stein PD, Alpert JS, Copeland J, Dalen JE, Goldman S, Turpie AG. Antithrombotic therapy in patients with mechanical and biological prosthetic heart valves. Chest. 1995 Oct;108(4 Suppl):371S-379S. doi: 10.1378/chest.108.4_supplement.371s. No abstract available.
- Background: PubMed 10559081Douketis JD, Crowther MA, Cherian SS, Kearon CB. Physician preferences for perioperative anticoagulation in patients with a mechanical heart valve who are undergoing elective noncardiac surgery. Chest. 1999 Nov;116(5):1240-6. doi: 10.1378/chest.116.5.1240.
- Background: PubMed 12719198Dunn AS, Turpie AG. Perioperative management of patients receiving oral anticoagulants: a systematic review. Arch Intern Med. 2003 Apr 28;163(8):901-8. doi: 10.1001/archinte.163.8.901.
- Individual participant dataSharing planned: No
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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.
Michael J Kovacs, MD, FRCPC principal investigator
University of Western Ontario, Canada
8 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Dalteparin in people with Stroke, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 8 sites in 2 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 5 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 19 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Canada, India. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
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?
major thromboembolism (time frame: 90 days from randomization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00432796, which also lists 46 linked publications.
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 19 Feb 2020.