Dalteparin vs Unfractionated Heparin For The Prevention Of Venous Thromboembolism (VTE) In Hospitalized Acutely Ill Medical Patients - Study Results

Study Type:	Interventional
Study Design:	Randomized, Open Label, Parallel Assignment
Condition:	Venous Thromboembolism
Interventions:	Drug: Dalteparin (Fragmin) Drug: Unfractionated heparin

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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	Description
Dalteparin	5000 IU (International Units) dalteparin in 0.2 mL (milliliters) subcutaneously once a day (Arm A)
Unfractionated Heparin	5000 IU unfractionated Heparin (UFH) in 5 mL subcutaneously 3 times a day (Arm B) for 6 to 14 days.

	Dalteparin	Unfractionated Heparin
STARTED	42	42
Received Treatment	41^[1]	42
COMPLETED	39	36
NOT COMPLETED	3	6
Death	0	1
Adverse Event	0	3
unknown	0	2
Withdrawal by Subject	2	0
Protocol Violation	1	0

[1]	1 subject discontinued after enrollment but prior to study treatment.

	Dalteparin	Unfractionated Heparin	Total
Number of Participants [units: participants]	41	42	83
Age [units: years] Mean ± Standard Deviation	61.7 ± 10.6	60.8 ± 10.9	61.3 ± 10.7
Gender [units: participants]
Female	18	21	39
Male	23	21	44

Outcome Measures

1. Primary:

Confirmed Thromboembolic Events [ Day 21 ]

Measure Type	Primary
Measure Title	Confirmed Thromboembolic Events
Measure Description	Confirmed thromboembolic events = 'present' if any following events are present/abnormal, otherwise = 'absent': Deep vein thrombosis measured by Color Doppler ultrasonography lower limbs; pulmonary embolism by chest xray, ventilation-perfusion scan, computed tomography pulmonary angiography; Sudden Death within 24 hours of venous thromboembolism symptoms.
Time Frame	Day 21
Safety Issue	Yes

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Intent to treat (ITT) set: all subjects who were randomized, received at least 1 dose of study drug and had undergone at least 1 test of primary efficacy assessment.

Reporting Groups

	Description
Dalteparin	5000 IU dalteparin in 0.2 mL subcutaneously once a day (Arm A)
Unfractionated Heparin	5000 IU unfractionated Heparin (UFH) in 5 mL subcutaneously 3 times a day (Arm B) for 6 to 14 days.

Measured Values

	Dalteparin	Unfractionated Heparin
Number of Participants Analyzed [units: participants]	37	35
Confirmed Thromboembolic Events [units: participants]
Present	0	0
Absent	37	35

No statistical analysis provided for Confirmed Thromboembolic Events

2. Primary:

Composite of Objectively Verified Thromboembolic Events [ Day 21 ]

Measure Type	Primary
Measure Title	Composite of Objectively Verified Thromboembolic Events
Measure Description	Subjects with objectively verified thromboembolic events: symptomatic proximal and distal deep vein thrombosis [DVT], asymptomatic proximal DVT, fatal or symptomatic non-fatal pulmonary embolism [PE] or sudden death within 24 hours of onset of venous thromboembolism (VTE) symptoms. Occurrence of any ='Present', otherwise = 'Absent'.
Time Frame	Day 21
Safety Issue	Yes

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Intent to treat (ITT)

Reporting Groups

	Description
Dalteparin	5000 IU dalteparin in 0.2 mL subcutaneously once a day (Arm A)
Unfractionated Heparin	5000 IU unfractionated Heparin (UFH) in 5 mL subcutaneously 3 times a day (Arm B) for 6 to 14 days.

Measured Values

	Dalteparin	Unfractionated Heparin
Number of Participants Analyzed [units: participants]	37	35
Composite of Objectively Verified Thromboembolic Events [units: participants]
Symptomatic DVT Present	0	0
Symptomatic DVT Absent	37	35
Symptomatic Proximal DVT Present	0	0
Symptomatic Proximal DVT Absent	37	35
Symptomatic Distal DVT Present	0	0
Symptomatic Distal DVT Absent	37	35
Asymptomatic Proximal DVT Present	0	0
Asymptomatic Proximal DVT Absent	37	35
Fatal pulmonary embolism Present	0	0
Fatal pulmonary embolism Absent	37	35
Symptomatic non-fatal pulmonary embolism Present	0	0
Symptomatic non-fatal pulmonary embolism Absent	37	35
Sudden Death within 24 hours of VTE Present	0	0
Sudden Death within 24 hours of VTE Absent	37	35

No statistical analysis provided for Composite of Objectively Verified Thromboembolic Events

3. Secondary:

All Cause Mortality [ Day 14, Day 21 (End of Study) ]

Measure Type	Secondary
Measure Title	All Cause Mortality
Measure Description	Subjects with death from any cause: end of study.
Time Frame	Day 14, Day 21 (End of Study)
Safety Issue	Yes

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Intent to treat (ITT)

Reporting Groups

	Description
Dalteparin	5000 IU dalteparin in 0.2 mL subcutaneously once a day (Arm A)
Unfractionated Heparin	5000 IU unfractionated Heparin (UFH) in 5 mL subcutaneously 3 times a day (Arm B) for 6 to 14 days.

Measured Values

	Dalteparin	Unfractionated Heparin
Number of Participants Analyzed [units: participants]	37	37
All Cause Mortality [units: participants]	0	1

Statistical Analysis 1 for All Cause Mortality

Groups ^[1]	All groups
Method ^[2]	Chi-squared
P Value ^[3]	1.0000

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[2]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	P-value is based on chi-square test with alpha as 0.01.

4. Secondary:

Stroke - Ischemic or Hemorrhagic [ Day 21 ]

Measure Type	Secondary
Measure Title	Stroke - Ischemic or Hemorrhagic
Measure Description	Subjects with stroke (either ischemic or hemorrhagic) based on results of CT (computed tomographic) pulmonary angiography
Time Frame	Day 21
Safety Issue	Yes

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Intent to treat (ITT)

Reporting Groups

	Description
Dalteparin	5000 IU dalteparin in 0.2 mL subcutaneously once a day (Arm A)
Unfractionated Heparin	5000 IU unfractionated Heparin (UFH) in 5 mL subcutaneously 3 times a day (Arm B) for 6 to 14 days.

Measured Values

	Dalteparin	Unfractionated Heparin
Number of Participants Analyzed [units: participants]	37	37
Stroke - Ischemic or Hemorrhagic [units: participants]	0	0

No statistical analysis provided for Stroke - Ischemic or Hemorrhagic

5. Secondary:

Bleeding - Major or Minor [ Day 21 ]

Measure Type	Secondary
Measure Title	Bleeding - Major or Minor
Measure Description	Subjects with bleeding. Bleeding classified as major if it is: intraocular, spinal/epidural, intracranial or retroperitoneal; or if hemoglobin decreased by ≥ 2 g/dl(grams/deciliter); or if transfusion of ≥ 2 Units of blood or if significant medical or surgical intervention was required; or if it results in death. All other bleeding is classified as minor.
Time Frame	Day 21
Safety Issue	Yes

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Intent to treat (ITT)

Reporting Groups

	Description
Dalteparin	5000 IU dalteparin in 0.2 mL subcutaneously once a day (Arm A)
Unfractionated Heparin	5000 IU unfractionated Heparin (UFH) in 5 mL subcutaneously 3 times a day (Arm B) for 6 to 14 days.

Measured Values

	Dalteparin	Unfractionated Heparin
Number of Participants Analyzed [units: participants]	37	37
Bleeding - Major or Minor [units: participants]
Major Bleeding	0	1
Minor Bleeding	0	0

Statistical Analysis 1 for Bleeding - Major or Minor

Groups ^[1]	All groups
Method ^[2]	Chi-squared
P Value ^[3]	1.0000

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Major Bleeding
[2]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	No text entered.

6. Secondary:

Allergic Reactions (Drug-related) [ Day 21 ]

Measure Type	Secondary
Measure Title	Allergic Reactions (Drug-related)
Measure Description	Subjects with drug-related allergic reactions
Time Frame	Day 21
Safety Issue	Yes

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Intent to treat (ITT)

Reporting Groups

	Description
Dalteparin	5000 IU dalteparin in 0.2 mL subcutaneously once a day (Arm A)
Unfractionated Heparin	5000 IU unfractionated Heparin (UFH) in 5 mL subcutaneously 3 times a day (Arm B) for 6 to 14 days.

Measured Values

	Dalteparin	Unfractionated Heparin
Number of Participants Analyzed [units: participants]	37	37
Allergic Reactions (Drug-related) [units: participants]	0	0

No statistical analysis provided for Allergic Reactions (Drug-related)

7. Secondary:

Thrombocytopenia [ Day 21 ]

Measure Type	Secondary
Measure Title	Thrombocytopenia
Measure Description	Subjects with thrombocytopenia (low platelets).
Time Frame	Day 21
Safety Issue	Yes

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Intent to Treat (ITT)

Reporting Groups

	Description
Dalteparin	5000 IU dalteparin in 0.2 mL subcutaneously once a day (Arm A)
Unfractionated Heparin	5000 IU unfractionated Heparin (UFH) in 5 mL subcutaneously 3 times a day (Arm B) for 6 to 14 days.

Measured Values

	Dalteparin	Unfractionated Heparin
Number of Participants Analyzed [units: participants]	37	37
Thrombocytopenia [units: participants]	35	31

Statistical Analysis 1 for Thrombocytopenia

Groups ^[1]	All groups
Method ^[2]	Chi-squared
P Value ^[3]	0.1355

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[2]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	No text entered.

More Information

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Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: Pfizer has the right to review disclosures, requesting a delay of < 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), < 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Study terminated prematurely due to delay in overall study start-up and inability to meet predefined protocol recruitment milestones; sample size too small to permit meaningful statistical analyses. No statistical analyses for all but 2 endpoints.

Results Point of Contact:

Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
phone: 1-800-718-1021
e-mail: ClinicalTrials.govCallCenter@pfizer.com

No publications provided

Responsible Party:	Pfizer Inc ( Director, Clinical Trial Disclosure Group )
Study ID Numbers:	A6301080
Study First Received:	March 7, 2007
Results First Received:	July 20, 2009
Last Updated:	October 5, 2009
ClinicalTrials.gov Identifier:	NCT00445328 History of Changes
Health Authority:	India: Institutional Review Board