NCT00191724

Brief Summary

An exploratory, multicenter, randomized, placebo-controlled, double blind, dose escalation study comparing a standard therapy for submassive pulmonary embolism (Enoxaparin sodium) to a combined therapy of Drotrecogin alfa (activated) plus Enoxaparin sodium.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
47

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Sep 2004

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2004

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

September 12, 2005

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 19, 2005

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2008

Completed
1.5 years until next milestone

Results Posted

Study results publicly available

June 17, 2009

Completed
Last Updated

June 24, 2009

Status Verified

June 1, 2009

Enrollment Period

3.3 years

First QC Date

September 12, 2005

Results QC Date

January 14, 2009

Last Update Submit

June 16, 2009

Conditions

Submassive Pulmonary Embolism

Outcome Measures

Primary Outcomes (1)

  • Number of Participants With Major Bleeding Events

    Number of patients with major bleeding events, defined as: Reduction in hemoglobin of 2 to 5 grams per deciliter (g/dL) within 24 hours; Transfusion of 2 to 4 units of packed red blood cells within 24 hours; Hematoma requiring prolonged hospitalization or surgical intervention; Intracranial or retroperitoneal hemorrhage.

    baseline through day 6

Secondary Outcomes (3)

  • Right Ventricular Enddiastolic Area/Left Ventricular Enddiastolic Area (RVEDA/LVEDA) Ratios

    baseline, day 6, day 90

  • Chronic Respiratory Questionnaire Self-Administered Standardized Format (CRQ-SAS of the McMaster University Canada)

    baseline and day 90 (follow-up)

  • Difference in Pulmonary Artery (PA) Pressure

    baseline, day 6, day 90

Study Arms (5)

1

EXPERIMENTAL
Drug: Drotrecogin Alfa (Activated)Drug: Enoxaparin

2

EXPERIMENTAL
Drug: EnoxaparinDrug: Drotrecogin Alfa (Activated)

3

EXPERIMENTAL
Drug: EnoxaparinDrug: Drotrecogin Alfa (Activated)

4

EXPERIMENTAL
Drug: EnoxaparinDrug: Drotrecogin Alfa (Activated)

5

PLACEBO COMPARATOR
Drug: EnoxaparinDrug: Placebo

Interventions

Drotrecogin Alfa (Activated)DRUG

6 micrograms/kilograms/hour (ug/kg/hr), intravenous (IV), one infusion, over 12 hours

Also known as: Xigris, LY203638
1
EnoxaparinDRUG

1 milligram/kilogram (mg/kg), subcutaneous, every 12 hours until the target International Normalized Ratio (INR) is reached, minimum of 5 days

12345
PlaceboDRUG

intravenous (IV), one infusion, over 12 hours

5

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Clinical symptoms of Pulmonary embolism for less than 48 hours

You may not qualify if:

  • Patients with symptoms of Pulmonary embolism for more than 48 hours

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Mannheim, Germany

Location

Related Publications (1)

  • Dempfle CE, Elmas E, Link A, Suvajac N, Liebe V, Janes J, Borggrefe M. Endogenous plasma activated protein C levels and the effect of enoxaparin and drotrecogin alfa (activated) on markers of coagulation activation and fibrinolysis in pulmonary embolism. Crit Care. 2011;15(1):R23. doi: 10.1186/cc9968. Epub 2011 Jan 17.

    PMID: 21241489DERIVED

Related Links

MeSH Terms

Interventions

drotrecogin alfa activatedEnoxaparin

Intervention Hierarchy (Ancestors)

Heparin, Low-Molecular-WeightHeparinGlycosaminoglycansPolysaccharidesCarbohydrates

Limitations and Caveats

This study was stopped early after 47 patients had been enrolled (planned enrollment was 48 patients). Study was stopped early due to slow enrollment.

Results Point of Contact

Title
Chief Medical Officer
Organization
Eli Lilly and Company
1-800-545-5979

Study Officials

  • Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern Time (UTC/GMT - 5 hours, EST)

    Eli Lilly and Company

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
GT60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 12, 2005

First Posted

September 19, 2005

Study Start

September 1, 2004

Primary Completion

January 1, 2008

Study Completion

January 1, 2008

Last Updated

June 24, 2009

Results First Posted

June 17, 2009

Record last verified: 2009-06

Locations

DE(1)