Submitted by: Geraldine Guerina 2015-10-07 00:00:00 Last Updated by: Geraldine Guerina 2019-12-02 09:45:43


RE-COVERY DVT/PE: global study on treatment and secondary prevention of acute venous thromboembolism

PHRR151015-001103

1160.188

Unspecified

Characterization of patients following acute venous thromboembolism (VTE) and assessment of safety and effectiveness of dabigatran etexilate (DE) in the treatment and secondary prevention of acute deep vein thrombosis (DVT) and pulmonary embolism (PE) in comparison to vitamin K antagonist (VKA) in routine clinical practice - RE-COVERY DVT/PE

multi-national, multi-center observational study based on new data collection

Regime Classification Priority
2010 - 2016 Health Technology Development Drug Discovery and Development
Start Date Duration in Months Target Completion Date Actual Completion Date
2016-01-04 30 2018-07-04 2018-04-30

Completed

Institution Classification Region LTO #
Boehringer Ingelheim (Philippines), Inc. Private Business NCR N/A
Institution Classification Region LTO #
PAREXEL Clinical Research (Philippines) Ltd. Corp. Private Business NCR CDRR-NCR-CRO-4
Institution Region
Boehringer Ingelheim (Philippines), Inc. NCR
Name E-Mail Phone Number Postal Address
Aye Reece Bartocillo AyeReece.Bartocillo@PAREXEL.com +63.2.988.6286 15th Floor, Philam Life Tower 8767 Paseo de Roxas Makati City, 1226 Philippines
Name E-Mail Phone Number Postal Address
Maaliddin Biruar Maaliddin.Biruar@parexel.com 632 988 9201 5th Floor, Philam Life Tower 8767 Paseo de Roxas Makati City, 1226 Philippines
Name Expertise Affiliation
Adelina Paule Cardiologist Metropolitan Medical Center
Diana Jean Roxas, MD Cardiologist St. Luke's Medical Center - Quezon City
Fatima Collado, MD Cardiologist St. Luke's Medical Center - Quezon City
Lenora Cañizares-Fernandez, MD Cardiologist Philippine General Hospital
Mary Milagros Uy Cardiologist Makati Medical Center
Project Location Institutional Ethics Review Board
Metropolitan Medical Center Institutional Review Board of Metropolitan Medical Center, Inc.
St. Luke's Medical Center - Quezon City St. Luke's Medical Center Institutional Ethics Review Board
St. Luke's Medical Center - Quezon City St. Luke's Medical Center Institutional Ethics Review Board
Philippine General Hospital Philippine General Hospital Ethics Review Board
Makati Medical Center Makati Medical Center Institutional Review Board

diagnosed with an acute DVT and/or PE

  • Primary safety outcome measure: Major bleeding(International Society on Thrombosis and Haemostasis(ISTH) criteria)
  • Primary effectiveness outcome measure: symptomatic recurrent VTE including VTE-related mortality

  • Recurrent DVT and/or PE
  • VTE-related mortality
  • All-cause mortality

Completed

  • Philippines

Clinical Trial

Unspecified

2015-09-23

Date Amendment Classification Reason
2016-05-17 Amendments related to the trial arrangements Change of the principal investigator or addition of new ones
2016-05-17 Amendments related to the trial arrangements Change of the trial site or addition of new site
2017-02-15 Amendments related to the protocol Inclusion criteria
2017-12-13 Amendments related to the protocol Statistical analysis

Inclusion Criteria:
1. Written informed consent provided by the patient or the patient’s legal representative
in accordance with local regulations
2. Diagnosis of an acute DVT irrespective of location and/or PE (For objective 1, assessment of patient for study participation should be done ideally within 14 days but not more than 6 months after diagnosis of the acute VTE.  For Objective 2, patient assessment should occur ideally within 14 days but not more than 30 days from diagnosis)
3. Age ≥ 18 years
4. For Objective 2, the planned anticoagulation therapy should be for at least 3 months
5. For Objective 2, dabigatran etexilate and VKA patients should be available for
follow-up data collection (clinic or via phone) at the specified timeframes

Exclusion criteria
1. On active or prophylactic anticoagulation therapy for conditions other than VTE. Ongoing anticoagulation treatment due to history of previous VTE is not considered an exclusion criteria. Anticoagulation therapy given for planned surgery is not considered an exclusion criteria.
2. Current participation in a clinical trial for VTE indication or current use of an unapproved (i.e., investigational) drug

Observational

Unspecified

Unspecified

Unspecified

Open Label

Unspecified

Not Applicable

  • To characterize the DVT / PE patient population including the initial acute event phase. All patients with a DVT and/or PE will be enrolled for cross-sectional characterization of the VTE patient population and descriptions of current treatment patterns, and stratified by geographical location.
  • To analyze the safety and effectiveness of dabigatran etexilate regimens in the treatment of DVT and PE over 1 year of follow-up in comparison to a VKA regimen.

Phase IV

60

34

Unspecified

04 Jan 2016

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