Trial Outcomes & Findings for Epidemiology of Thromboembolism Disease: A Cohort Study (NCT NCT00670540)

NCT ID: NCT00670540

Last Updated: 2012-05-08

Results Overview

new VTE which can occur during follow up for no VTE patients at inclusion. Or VTE recurrence for VTE patients at inclusion.

• Recruitment status: COMPLETED
• Target enrollment: 8256 participants
• Primary outcome timeframe: at 3 years
• Results posted on: 2012-05-08

Participant Flow

Participant milestones

Measure	OPTIMEV patients with suspected Deep Vein Thrombosis (DVT) or Pulmonary Embolism (PE)
Overall Study STARTED	8256
Overall Study COMPLETED	4931
Overall Study NOT COMPLETED	3325

Reasons for withdrawal

Measure	OPTIMEV patients with suspected Deep Vein Thrombosis (DVT) or Pulmonary Embolism (PE)
Overall Study ineligible	17
Overall Study not living in France	348
Overall Study refused to participate	189
Overall Study controls randomised for no follow up	2770
Overall Study missing information inclusion criteria	1

Baseline Characteristics

Epidemiology of Thromboembolism Disease: A Cohort Study

Baseline characteristics by cohort

Measure	OPTIMEV n=8256 Participants patients with suspected Deep Vein Thrombosis (DVT) or Pulmonary Embolism (PE)
Age Continuous	62 years STANDARD_DEVIATION 18 • n=5 Participants
Sex: Female, Male Female	5063 Participants n=5 Participants
Sex: Female, Male Male	3193 Participants n=5 Participants
Region of Enrollment France	7908 participants n=5 Participants
Region of Enrollment Guadeloupe	321 participants n=5 Participants
Region of Enrollment Belgium	27 participants n=5 Participants

PRIMARY outcome

Timeframe: at 3 years

new VTE which can occur during follow up for no VTE patients at inclusion. Or VTE recurrence for VTE patients at inclusion.

Outcome measures

Measure	OPTIMEV n=4931 Participants patients with suspected Deep Vein Thrombosis (DVT) or Pulmonary Embolism (PE)
Percentage of Participants Who Developed a New or Recurrence of Venous Thromboembolism (VTE)	8.94 percentage of participants Interval 8.14 to 9.83

SECONDARY outcome

Timeframe: at 3 years

Outcome measures

Measure	OPTIMEV n=4931 Participants patients with suspected Deep Vein Thrombosis (DVT) or Pulmonary Embolism (PE)
Percentage of Participants Who Developed Major Bleeding Events	3.00 percentage of participants Interval 2.54 to 3.54

SECONDARY outcome

Timeframe: after inclusion

Outcome measures

Measure	OPTIMEV n=4931 Participants patients with suspected Deep Vein Thrombosis (DVT) or Pulmonary Embolism (PE)
Percentage of Participants With Treatment Anticoagulant Prescribed	52.23 percentage of participants Interval 50.82 to 53.63

SECONDARY outcome

Timeframe: at 3 years

Outcome measures

Measure	OPTIMEV n=4931 Participants patients with suspected Deep Vein Thrombosis (DVT) or Pulmonary Embolism (PE)
Percentage of Participants Who Developed Cardiovascular Events	6.98 percentage of participants Interval 6.26 to 7.77

SECONDARY outcome

Timeframe: at 3 years

Outcome measures

Measure	OPTIMEV n=4931 Participants patients with suspected Deep Vein Thrombosis (DVT) or Pulmonary Embolism (PE)
Percentage of Participants Who Died From Any Cause	17.0 percentage of participants Interval 15.9 to 18.0

SECONDARY outcome

Timeframe: at 3 years

Outcome measures

Measure	OPTIMEV n=4931 Participants patients with suspected Deep Vein Thrombosis (DVT) or Pulmonary Embolism (PE)
Percentage of Participants Who Developed Cancer Onset	4.10 percentage of participants Interval 3.56 to 4.73

SECONDARY outcome

Timeframe: at 3 years

Outcome measures

Measure	OPTIMEV n=4931 Participants patients with suspected Deep Vein Thrombosis (DVT) or Pulmonary Embolism (PE)
Percentage of Participants Who Developed Venous Insufficiency (Leg Ulcer)	0.34 percentage of participants Interval 0.2 to 0.55

Adverse Events

OPTIMEV

Serious events: 1147 serious events

Other events: 273 other events

Deaths: 0 deaths

Serious adverse events

Measure	OPTIMEV n=4931 participants at risk patients with suspected Deep Vein Thrombosis (DVT) or Pulmonary Embolism (PE)
General disorders death	16.7% 822/4931
Neoplasms benign, malignant and unspecified (incl cysts and polyps) cancer	3.7% 182/4931
Cardiac disorders cardiovascular	6.3% 310/4931
Blood and lymphatic system disorders haemorrhage	2.7% 135/4931
Vascular disorders Pulmonary Embolism (PE)	2.5% 122/4931

Other adverse events

Measure	OPTIMEV n=4931 participants at risk patients with suspected Deep Vein Thrombosis (DVT) or Pulmonary Embolism (PE)
Vascular disorders Deep Vein Thrombosis (DVT)	3.8% 186/4931
Vascular disorders Superficial Vein Thrombosis (SVT)	1.6% 81/4931
Vascular disorders Upper Deep Vein Thrombosis	0.12% 6/4931

Additional Information

Jean-Luc Bosson

University Hospital Grenoble

Phone: 33 4 76 76 50 40

Email: jean-luc.bosson@imag.fr

Results disclosure agreements

• Principal investigator is a sponsor employee The protocol OPTIMEV will follow the international recommendations: "Uniforms Requirements for Manuscripts Submitted to Biomedical Journals" (http://www.icmje.org)
• Publication restrictions are in place

Restriction type: OTHER