ThromboembolismNCT00967447

Study to Evaluate the Safety and Efficacy of Pradaxar for the Prevention of Venous Thromboembolism in the Mexican Population Undergoing Elective Total Hip or Knee Replacement Surgery

An observational study of Thromboembolism and Arthroplasty, Replacement, Hip, run by Boehringer Ingelheim at 28 sites in Mexico.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

Open, prospective, uncontrolled, observational cohort study. Read more about this study

Who is it for?: Ages 18 to 74 years
Conditions the study is for: Thromboembolism, Arthroplasty, Replacement, Hip
How many people: 2 participants
Where: 28 sitesMexico
Study dates: 1 Feb 2009to 1 Jan 2010
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 74 years
All sexes
No healthy volunteers
Adult, Older adult

Study population: Primary Care Clinics

Who may be able to join

patients age 18 years or above undergoing elective total hip or knee replacement surgery
Written informed consent obtained for data collection and source data verification.

Who cannot join

According to the approved label the following patients should not be treated with Pradaxar® 220mg q.d.:
age of > 75 years
renal impairment (creatinine clearance <50ml/min)
patients on concomitant therapy with amiodarone or verapamil.
elevated liver enzymes >2 upper limit of normal (ULN) and / or hepatic impairment or liver disease expected to have any impact on survival
anaesthesia with post-operative indwelling epidural catheters

Show all 11Show fewer

hypersensitivity to dabigatran etexilate or to any of the excipients
active clinically significant bleeding
organic lesion at risk of bleeding
spontaneous or pharmacological impairment of haemostasis except for the above-included patients groups
concomitant treatment with quinidine

Trial locations and contacts

28 sites in 1 country.

City, postcode or hospital

28 sites in 1 country

Mexico28 sites

Boehringer Ingelheim Investigational Site 10
Distrito Federal
Boehringer Ingelheim Investigational Site 11
Distrito Federal
Boehringer Ingelheim Investigational Site 12
Distrito Federal
Boehringer Ingelheim Investigational Site 13
Distrito Federal
Boehringer Ingelheim Investigational Site 14
Distrito Federal
Boehringer Ingelheim Investigational Site 15
Distrito Federal
Boehringer Ingelheim Investigational Site 16
Distrito Federal
Boehringer Ingelheim Investigational Site 17
Distrito Federal
Boehringer Ingelheim Investigational Site 18
Distrito Federal
Boehringer Ingelheim Investigational Site 19
Distrito Federal
Boehringer Ingelheim Investigational Site 1
Distrito Federal
Boehringer Ingelheim Investigational Site 20
Distrito Federal
Boehringer Ingelheim Investigational Site 2
Distrito Federal
Boehringer Ingelheim Investigational Site 3
Distrito Federal
Boehringer Ingelheim Investigational Site 4
Distrito Federal
Boehringer Ingelheim Investigational Site 5
Distrito Federal
Boehringer Ingelheim Investigational Site 6
Distrito Federal
Boehringer Ingelheim Investigational Site 7
Distrito Federal
Boehringer Ingelheim Investigational Site 8
Distrito Federal
Boehringer Ingelheim Investigational Site 9
Distrito Federal
Boehringer Ingelheim Investigational Site 21
Guadalajara
Boehringer Ingelheim Investigational Site 22
Guadalajara
Boehringer Ingelheim Investigational Site 23
Guadalajara
Boehringer Ingelheim Investigational Site 24
Guadalajara
Boehringer Ingelheim Investigational Site 25
Guadalajara
Boehringer Ingelheim Investigational Site 28
Monterrey
Boehringer Ingelheim Investigational Site 26
Puebla City
Boehringer Ingelheim Investigational Site 27
Puebla City

Other trials in Mexico

About this study

Official title: Incidence of Symptomatic Venous Thromboembolic Events and Major Bleeding Events After Dabigatran Etexilate in Patients Subject to Subject to Elective Total Hip or Knee Replacement Surgery.

Open, prospective, uncontrolled, observational cohort study.

Conditions: Thromboembolism, Arthroplasty, Replacement, Hip
Medical subject headings: Thromboembolism

What is being measured

The primary outcome is the main question the study is designed to answer.

Venous Thromboembolic Events
Measured: 6 Months

Secondary outcomes (3)

Major Bleeding Events (MBE)
Measured: From 12 To 37 Days
Major Extra Surgical Site Bleedings
Measured: From 12 To 37 Days
Volume of Wound Drainage
Measured: From 12 To 37 Days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Feb 20091 Jan 2010

First posted27 Aug 2009 (estimated)
Study start1 Feb 2009
Primary completion1 Jan 2010

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for ThromboembolismStudies of the same condition, open and under way.
More trials run by Boehringer IngelheimThe 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: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 2 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00967447
Sponsor's protocol ID: 1160.103
Status last verified: Jan 2025
First submitted: 13 Aug 2009
Last updated: 11 Feb 2025
Results posted: Yes, on ClinicalTrials.gov
Individual data sharing: No: Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents. Exceptions might apply, e.g. studies in products where Boehringer Ingelheim is not the license holder; studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; studies conducted in a single center or targeting rare diseases (in case of low number of patients and therefore limitations with anonymization). For more details refer to: https://www.mystudywindow.com/msw/datatransparency

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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REGN7508 Versus Apixaban and Enoxaparin for Thromboprophylaxis After Total Knee Arthroplasty in Adults
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RecruitingPhase 3
Treatment and Secondary Prevention of Venous Thromboembolism (VTE) in Adult Participants With Solid and Hematologic Cancers
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REGN7508 in Adult Participants for Prevention of Cancer-Associated Thrombosis
Cancer-Associated Thrombosis (CAT)
RecruitingPhase 3
REGN7508 Versus Acetylsalicylic Acid (ASA) for Venous Thromboprophylaxis After Total Knee Arthroplasty in Adult Participants
Symptomatic Venous Thromboembolism (VTE)

All Thromboembolism trials

Study at a glance

From the registry record, last updated by the sponsor on 11 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Incidence of Symptomatic Venous Thromboembolic Events and Major Bleeding Events After Dabigatran Etexilate in Patients Subject to Subject to Elective Total Hip or Knee Replacement Surgery.
ClinicalTrials.gov ID: NCT00967447
Acronym / sponsor ID: 1160.103
Conditions: Thromboembolism, Arthroplasty, Replacement, Hip
Study type: Observational
Recruitment status: Terminated
Enrolment: 2 participants (actual)
Lead sponsor: Boehringer IngelheimIndustry (pharma, biotech, devices)
Study start: 1 Feb 2009 (actual)
Primary completion: 1 Jan 2010 (actual)
First posted: 27 Aug 2009 (estimated)
Results: Posted 5 Apr 2012

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Open, prospective, uncontrolled, observational cohort study.

Study design

Observational model: Cohort
Time perspective: Prospective

Who may qualify

Ages: 18 to 74 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Primary Care Clinics

Key inclusion criteria (2 listed)

patients age 18 years or above undergoing elective total hip or knee replacement surgery
Written informed consent obtained for data collection and source data verification.

Key exclusion criteria (11 listed)

According to the approved label the following patients should not be treated with Pradaxar® 220mg q.d.:
age of > 75 years
renal impairment (creatinine clearance <50ml/min)
patients on concomitant therapy with amiodarone or verapamil.
elevated liver enzymes >2 upper limit of normal (ULN) and / or hepatic impairment or liver disease expected to have any impact on survival

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Primary outcome

Venous Thromboembolic Events
Time frame: 6 Months

3 secondary outcomes

Major Bleeding Events (MBE)
Time frame: From 12 To 37 Days
Major Extra Surgical Site Bleedings
Time frame: From 12 To 37 Days
Volume of Wound Drainage
Time frame: From 12 To 37 Days

Results and safety

Results posted to the registry on 5 Apr 2012, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Dabigatran Exilate 220 Once Daily (OD)	2	2

Primary outcome: Venous Thromboembolic Events

Time frame: 6 Months

Population analysed: The trial was stopped due poor enrollment

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: 6 months. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Dabigatran Exilate 220 Once Daily (OD)	0 of 2 (0%)	0 of 2 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related InfoLink provided by the sponsor.
Individual participant dataSharing planned: No. Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents. Exceptions might apply, e.g. studies in products where Boehringer Ingelheim is not the license holder; studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; studies conducted in a single center or targeting rare diseases (in case of low number of patients and therefore limitations with anonymization). For more details refer to: https://www.mystudywindow.com/msw/datatransparency

Related trials for Thromboembolism

Not yet recruitingPhase 3
TicAgreLor Versus Placebo to Prevent Cerebral ISCHemia in anEuRysmal Low Grade SAH A Double Blinded Randomised Controlled Study
Subarachnoid Hemorrhage, Aneurysmal, Brain Ischemia
RecruitingPhase 3
REGN7508 Versus Apixaban and Enoxaparin for Thromboprophylaxis After Total Knee Arthroplasty in Adults
Venous Thromboembolism (VTE)
RecruitingPhase 3
Treatment and Secondary Prevention of Venous Thromboembolism (VTE) in Adult Participants With Solid and Hematologic Cancers
Venous Thromboembolism (VTE)
RecruitingPhase 3
REGN7508 in Adult Participants for Prevention of Cancer-Associated Thrombosis
Cancer-Associated Thrombosis (CAT)
RecruitingPhase 3
REGN7508 Versus Acetylsalicylic Acid (ASA) for Venous Thromboprophylaxis After Total Knee Arthroplasty in Adult Participants
Symptomatic Venous Thromboembolism (VTE)

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.

Boehringer Ingelheim study chair

Boehringer Ingelheim

28 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Thromboembolism and Arthroplasty, Replacement, Hip, run by Boehringer Ingelheim at 28 sites in Mexico.

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 2 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: stopped early, as of the sponsor's last update on 11 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 28 sites in Mexico. 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.

Are results available for this study?

Yes. Results are posted in the registry (first posted 5 Apr 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Venous Thromboembolic Events (time frame: 6 Months). 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 NCT00967447.

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 11 Feb 2025.