Submassive Pulmonary EmbolismPhase 2NCT00191724
Adjuvant Treatment of Pulmonary Embolism With Drotrecogin Alfa (Activated): Phase II Exploratory Study
A Phase 2 study testing Drotrecogin Alfa (Activated) and Enoxaparin in people with Submassive Pulmonary Embolism, run by Eli Lilly and Company at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Submassive Pulmonary Embolism
- What is being tested?
- Drotrecogin Alfa (Activated) and Enoxaparin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 47 participants
- Where
- 1 siteGermany
- Study dates
- Sep 2004to Jan 2008
- Phase
- Phase 2
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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical symptoms of Pulmonary embolism for less than 48 hours
Who cannot join
- Patients with symptoms of Pulmonary embolism for more than 48 hours
Trial locations and contacts
1 site in 1 country.
Germany1 site
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
About this study
Official title: Drotrecogin Alfa (Activated) (LY203638)] Exploratory, Safety Study, Multi-Center, Randomized, Placebo-Controlled, Dose Escalating Study Design, Comparing a Standard Therapy (Enoxaparin Sodium) for Submassive Pulmonary Embolism to a Combined Therapy of Drotrecogin Alfa (Activated) Plus Enoxaparin Sodium.
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.
- Conditions
- Submassive Pulmonary Embolism
- Being tested
- Drotrecogin Alfa (Activated), Enoxaparin, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Drotrecogin Alfa (Activated)Drug
Also called Xigris, LY203638
6 micrograms/kilograms/hour (ug/kg/hr), intravenous (IV), one infusion, over 12 hours
EnoxaparinDrug
1 milligram/kilogram (mg/kg), subcutaneous, every 12 hours until the target International Normalized Ratio (INR) is reached, minimum of 5 days
PlaceboDrug
intravenous (IV), one infusion, over 12 hours
Drotrecogin Alfa (Activated)Drug
Also called Xigris, LY203638
12 micrograms/kilograms/hour (ug/kg/hr), intravenous (IV), one infusion, over 12 hours
Drotrecogin Alfa (Activated)Drug
Also called Xigris, LY203638
18 micrograms/kilograms/hour (ug/kg/hr), intravenous (IV), one infusion, over 12 hours
Drotrecogin Alfa (Activated)Drug
Also called Xigris, LY203638
24 micrograms/kilograms/hour (ug/kg/hr), intravenous (IV), one infusion, over 12 hours
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: Drotrecogin Alfa (Activated); Drug: Enoxaparin |
| 2 | Experimental | Not described Receives: Drug: Enoxaparin; Drug: Drotrecogin Alfa (Activated) |
| 3 | Experimental | Not described Receives: Drug: Enoxaparin; Drug: Drotrecogin Alfa (Activated) |
| 4 | Experimental | Not described Receives: Drug: Enoxaparin; Drug: Drotrecogin Alfa (Activated) |
| 5 | Placebo comparator | Not described Receives: Drug: Enoxaparin; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: baseline through day 6
Secondary outcomes (3)
Right Ventricular Enddiastolic Area/Left Ventricular Enddiastolic Area (RVEDA/LVEDA) Ratios
Change of right ventricular function measured as difference of right ventricular enddiastolic area/left ventricular enddiastolic area (RVEDA/LVEDA) ratios by echocardiography
Measured: baseline, day 6, day 90
Chronic Respiratory Questionnaire Self-Administered Standardized Format (CRQ-SAS of the McMaster University Canada)
Scores in each of the 4 domains (dyspnea, fatigue, emotional, and mastery) ranged from 1 (maximum impairment) to 7 (no impairment).
Measured: baseline and day 90 (follow-up)
Difference in Pulmonary Artery (PA) Pressure
Investigator decided estimate of pulmonary artery pressure by echocardiography would not be useful and no data on pulmonary artery pressure were collected.
Measured: baseline, day 6, day 90
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2005 (estimated)
- Study startSep 2004
- Primary completionJan 2008
- Study completionJan 2008
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Submassive Pulmonary EmbolismStudies of the same condition, open and under way.
- More trials run by Eli Lilly and CompanyThe 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eli Lilly and Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- 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), Study director, Eli Lilly and Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00191724
- Sponsor's protocol ID
- 8354
- Other IDs
- F1K-MC-O014
- Status last verified
- Jun 2009
- First submitted
- 12 Sep 2005
- Last updated
- 24 Jun 2009
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
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.
PubMed 21241489