Trial Outcomes & Findings for Effectiveness And Safety Of Dalteparin In Patients With Acute Coronary Syndromes Without ST Elevations In Clinical Practice (NCT NCT00922766)

NCT ID: NCT00922766

Last Updated: 2012-01-23

Results Overview

Bleeding events were considered major if, accompanied by a decrease in hemoglobin of more than or equal to 2 grams/deciliter (g/dL) in connection with clinical symptoms; a transfusion was required; bleeding led to interruption of treatment or death; or intracranial bleeding.

• Recruitment status: COMPLETED
• Target enrollment: 618 participants
• Primary outcome timeframe: Baseline to 28 days after last dose of study drug
• Results posted on: 2012-01-23

Participant Flow

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.

Participant milestones

Measure	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.
Overall Study STARTED	617
Overall Study COMPLETED	610
Overall Study NOT COMPLETED	7

Reasons for withdrawal

Measure	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.
Overall Study Death	3
Overall Study Withdrawal by Subject	2
Overall Study Other	1
Overall Study Adverse Event	1

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Dalteparin n=617 Participants 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.
Age Continuous	57.5 years STANDARD_DEVIATION 12.6 • n=5 Participants
Sex: Female, Male Female	249 Participants n=5 Participants
Sex: Female, Male Male	368 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline to 28 days after last dose of study drug

Population: The full analysis set (FAS) included all enrolled participants who received at least 1 dose of the study medication.

Outcome measures

Measure	Dalteparin n=617 Participants 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.
Number of Participants With Death or Myocardial Infarction (MI)	3 Participants

PRIMARY outcome

Timeframe: Baseline to 28 days after last dose of study drug

Population: FAS included all enrolled participants who received at least 1 dose of the study medication.

Bleeding events were considered major if, accompanied by a decrease in hemoglobin of more than or equal to 2 grams/deciliter (g/dL) in connection with clinical symptoms; a transfusion was required; bleeding led to interruption of treatment or death; or intracranial bleeding.

Outcome measures

Measure	Dalteparin n=617 Participants 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.
Number of Participants With Major Bleeding Events	0 Participants

PRIMARY outcome

Timeframe: Baseline to 28 days after last dose of study drug

Population: FAS included all enrolled participants who received at least 1 dose of the study medication.

Bleeding events like hematuria, wound hematoma or injection site hematoma which did not fulfill the criteria for a major bleeding episode were classified as minor bleeding.

Outcome measures

Measure	Dalteparin n=617 Participants 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.
Number of Participants With Minor Bleeding Events	1 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline to 28 days after last dose of study drug

Population: FAS included all enrolled participants who received at least 1 dose of the study medication.

Stroke was defined as a sudden, focal neurologic deficit that was not reversible within 24 hours and was not the result of any readily identifiable cause (for example, tumor or trauma).

Outcome measures

Measure	Dalteparin n=617 Participants 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.
Number of Participants With Stroke	0 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline to 28 days after last dose of study drug

Population: FAS included all enrolled participants who received at least 1 dose of the study medication.

Cardiac arrest resuscitated was defined as sudden cessation of cardiac activity so that the participant became unresponsive, with no normal breathing and no signs of circulation. Cardiac arrest was used to signify an event that was reversed, usually by cardio-pulmonary resuscitation (CPR) and/or defibrillation or cardioversion, or cardiac pacing.

Outcome measures

Measure	Dalteparin n=617 Participants 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.
Number of Participants With Cardiac Arrest- Resuscitated	2 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline to 28 days after last dose of study drug

Population: FAS included all enrolled participants who received at least 1 dose of the study medication.

Thrombocytopenia was defined as a disorder in which there is an abnormally low platelet count. A normal platelet count ranged from 150,000 to 450,000 platelets per micro liter of blood.

Outcome measures

Measure	Dalteparin n=617 Participants 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.
Number of Participants With Heparin Induced Thrombocytopenia	0 Participants

Adverse Events

Dalteparin

Serious events: 4 serious events

Other events: 23 other events

Deaths: 0 deaths

Serious adverse events

Measure	Dalteparin n=617 participants at risk 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.
Cardiac disorders Cardiac Arrest	0.32% 2/617 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.
Cardiac disorders Cardio-respiratory Arrest	0.32% 2/617 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.
Cardiac disorders Left Ventricular Failure	0.16% 1/617 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.
Respiratory, thoracic and mediastinal disorders Pneumonia Aspiration	0.16% 1/617 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.
Respiratory, thoracic and mediastinal disorders Pneumonitis	0.16% 1/617 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.

Other adverse events

Measure	Dalteparin n=617 participants at risk 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.
Blood and lymphatic system disorders Anaemia	0.49% 3/617 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.
Gastrointestinal disorders Abdominal Pain	0.16% 1/617 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.
Gastrointestinal disorders Abdominal Pain Lower	0.16% 1/617 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.
Gastrointestinal disorders Gingival Bleeding	0.16% 1/617 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.
Gastrointestinal disorders Toothache	0.16% 1/617 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.
Gastrointestinal disorders Vomiting	0.16% 1/617 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.
General disorders Chest Pain	0.32% 2/617 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.
General disorders Chills	0.16% 1/617 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.
General disorders Pyrexia	0.49% 3/617 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.
Hepatobiliary disorders Hepatitis	0.16% 1/617 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.
Infections and infestations Lower Respiratory Tract Infections	0.16% 1/617 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.
Investigations Respiratory Rate	0.16% 1/617 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.
Musculoskeletal and connective tissue disorders Back Pain	0.16% 1/617 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.
Musculoskeletal and connective tissue disorders Myalgia	0.16% 1/617 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.
Nervous system disorders Headache	0.49% 3/617 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.
Nervous system disorders Hemiplegia	0.16% 1/617 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.
Respiratory, thoracic and mediastinal disorders Cough	0.16% 1/617 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.
Skin and subcutaneous tissue disorders Pruritus Generalised	0.16% 1/617 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.
Vascular disorders Venous Thrombosis	0.16% 1/617 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.

Additional Information

Pfizer ClinicalTrials.gov Call Center

Pfizer, Inc.

Phone: 1-800-718-1021

Email: ClinicalTrials.gov_Inquiries@pfizer.com

Results disclosure agreements

• Principal investigator is a sponsor employee 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.
• Publication restrictions are in place

Restriction type: OTHER