Acute Coronary Syndrome
Conditions
Keywords
dalteparin non-ST segment elevated acute coronary syndromes
Brief summary
To collect data on safety and effectiveness of dalteparin in the management of non-ST segment elevated acute coronary syndromes in nursing home patients who will be treated conservatively (without percutaneous corornary intervention \[PCI\] or coronary artery bypass graft \[CABG\] within 48 hours).
Detailed description
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Interventions
DRUGDalteparin
Patients prescribed dalteparin for non-ST segment elevated acute coronary syndromes in nursing home patients who will be treated conservatively (without corornary intervention \[PCI\] or coronary artery bypass graft \[CABG\] within 48 hours).
Sponsors
Pfizer
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Male or female patients of 18 years or more presenting with chest pain will be potentially eligible for inclusion in the study if they satisfy the criteria for unstable coronary artery disease per the investigator's routine practice and have received at least one injection of Fragmin (dalteparin sodium) as part of routine clinical practice and is expected to be treated conservatively (without PCI or CABG within 48 hours) during the index hospitalization. * Evidence of a personally signed and dated informed consent document indicating that the subject (or a legally acceptable representative) has been informed of all pertinent aspects of the study.
Exclusion criteria
* Patients who are contraindicated to receive this agent per the local approved prescribing information.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Death or Myocardial Infarction (MI) | Baseline to 28 days after last dose of study drug | — |
| Number of Participants With Major Bleeding Events | Baseline to 28 days after last dose of study drug | 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. |
| Number of Participants With Minor Bleeding Events | Baseline to 28 days after last dose of study drug | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Stroke | Baseline to 28 days after last dose of study drug | 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). |
| Number of Participants With Cardiac Arrest- Resuscitated | Baseline to 28 days after last dose of study drug | 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. |
| Number of Participants With Heparin Induced Thrombocytopenia | Baseline to 28 days after last dose of study drug | 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. |
Countries
India
Participant flow
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 617 |
| Total | 617 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 1 |
| Overall Study | Death | 3 |
| Overall Study | Other | 1 |
| Overall Study | Withdrawal by Subject | 2 |
Baseline characteristics
| Characteristic | Dalteparin |
|---|---|
| Age Continuous | 57.5 years STANDARD_DEVIATION 12.6 |
| Sex: Female, Male Female | 249 Participants |
| Sex: Female, Male Male | 368 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 23 / 617 |
| serious Total, serious adverse events | 4 / 617 |
Outcome results
Primary
Number of Participants With Death or Myocardial Infarction (MI)
Time frame: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Dalteparin | Number of Participants With Death or Myocardial Infarction (MI) | 3 Participants |
Primary
Number of Participants With Major Bleeding Events
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.
Time frame: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Dalteparin | Number of Participants With Major Bleeding Events | 0 Participants |
Primary
Number of Participants With Minor Bleeding Events
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.
Time frame: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Dalteparin | Number of Participants With Minor Bleeding Events | 1 Participants |
Other Pre-specified
Number of Participants With Cardiac Arrest- Resuscitated
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.
Time frame: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Dalteparin | Number of Participants With Cardiac Arrest- Resuscitated | 2 Participants |
Other Pre-specified
Number of Participants With Heparin Induced Thrombocytopenia
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.
Time frame: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Dalteparin | Number of Participants With Heparin Induced Thrombocytopenia | 0 Participants |
Other Pre-specified
Number of Participants With Stroke
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).
Time frame: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Dalteparin | Number of Participants With Stroke | 0 Participants |