Effectiveness And Safety Of Dalteparin In Patients With Acute Coronary Syndromes Without ST Elevations In Clinical Practice

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Pfizer

ClinicalTrials.gov Identifier:

NCT00922766

First received: June 16, 2009

Last updated: January 19, 2012

Last verified: January 2012

History of Changes

Results First Received: October 7, 2011

Study Type:	Observational
Study Design:	Observational Model: Case-Only; Time Perspective: Prospective
Condition:	Acute Coronary Syndrome
Intervention:	Drug: Dalteparin

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
A total of 618 participants were screened, of which 617 participant were assigned to study treatment and 1 participant was excluded based on investigator's discretion.

Reporting Groups

	Description
Dalteparin	Dalteparin Sodium 120 international units/kilogram (IU/kg) total body weight up to a maximum dose of 10,000 IU subcutaneously (s.c.) every 12 hours, for 1-2 weeks.

Participant Flow: Overall Study

	Dalteparin
STARTED	617
COMPLETED	610
NOT COMPLETED	7
Death	3
Withdrawal by Subject	2
Unspecified	1
Adverse Event	1

Baseline Characteristics

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Reporting Groups

	Description
Dalteparin	Dalteparin Sodium 120 international units/kilogram (IU/kg) total body weight up to a maximum dose of 10,000 IU subcutaneously (s.c.) every 12 hours, for 1-2 weeks.

Baseline Measures

	Dalteparin
Number of Participants [units: participants]	617
Age [units: years] Mean ± Standard Deviation	57.5 ± 12.6
Gender [units: participants]
Female	249
Male	368

Outcome Measures

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1. Primary:

Number of Participants With Death or Myocardial Infarction (MI) [ Time Frame: Baseline to 28 days after last dose of study drug ]

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2. Primary:

Number of Participants With Major Bleeding Events [ Time Frame: Baseline to 28 days after last dose of study drug ]

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3. Primary:

Number of Participants With Minor Bleeding Events [ Time Frame: Baseline to 28 days after last dose of study drug ]

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4. Other Pre-specified:

Number of Participants With Stroke [ Time Frame: Baseline to 28 days after last dose of study drug ]

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5. Other Pre-specified:

Number of Participants With Cardiac Arrest- Resuscitated [ Time Frame: Baseline to 28 days after last dose of study drug ]

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6. Other Pre-specified:

Number of Participants With Heparin Induced Thrombocytopenia [ Time Frame: Baseline to 28 days after last dose of study drug ]

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Serious Adverse Events

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Other Adverse Events

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Time Frame	No text entered.
Additional Description	The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.

Frequency Threshold

Threshold above which other adverse events are reported	0%

Reporting Groups

	Description
Dalteparin	Dalteparin Sodium 120 international units/kilogram (IU/kg) total body weight up to a maximum dose of 10,000 IU subcutaneously (s.c.) every 12 hours, for 1-2 weeks.

Other Adverse Events

	Dalteparin
Total, other (not including serious) adverse events
# participants affected / at risk	23/617
Blood and lymphatic system disorders
Anaemia ^{* 1}
# participants affected / at risk	3/617 (0.49%)
Gastrointestinal disorders
Abdominal Pain ^{* 1}
# participants affected / at risk	1/617 (0.16%)
Abdominal Pain Lower ^{* 1}
# participants affected / at risk	1/617 (0.16%)
Gingival Bleeding ^{* 1}
# participants affected / at risk	1/617 (0.16%)
Toothache ^{* 1}
# participants affected / at risk	1/617 (0.16%)
Vomiting ^{* 1}
# participants affected / at risk	1/617 (0.16%)
General disorders
Chest Pain ^{* 1}
# participants affected / at risk	2/617 (0.32%)
Chills ^{* 1}
# participants affected / at risk	1/617 (0.16%)
Pyrexia ^{* 1}
# participants affected / at risk	3/617 (0.49%)
Hepatobiliary disorders
Hepatitis ^{* 1}
# participants affected / at risk	1/617 (0.16%)
Infections and infestations
Lower Respiratory Tract Infections ^{* 1}
# participants affected / at risk	1/617 (0.16%)
Investigations
Respiratory Rate ^{* 1}
# participants affected / at risk	1/617 (0.16%)
Musculoskeletal and connective tissue disorders
Back Pain ^{* 1}
# participants affected / at risk	1/617 (0.16%)
Myalgia ^{* 1}
# participants affected / at risk	1/617 (0.16%)
Nervous system disorders
Headache ^{* 1}
# participants affected / at risk	3/617 (0.49%)
Hemiplegia ^{* 1}
# participants affected / at risk	1/617 (0.16%)
Respiratory, thoracic and mediastinal disorders
Cough ^{* 1}
# participants affected / at risk	1/617 (0.16%)
Skin and subcutaneous tissue disorders
Pruritus Generalised ^{* 1}
# participants affected / at risk	1/617 (0.16%)
Vascular disorders
Venous Thrombosis ^{* 1}
# participants affected / at risk	1/617 (0.16%)

*	Events were collected by non-systematic assessment
1	Term from vocabulary, MedDRA 13.1

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 less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 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
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Results Point of Contact:

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

No publications provided

Responsible Party:	Pfizer
ClinicalTrials.gov Identifier:	NCT00922766 History of Changes
Other Study ID Numbers:	A6301088
Study First Received:	June 16, 2009
Results First Received:	October 7, 2011
Last Updated:	January 19, 2012
Health Authority:	India: Institutional Review Board

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