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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1.0 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dalteparin | Drug | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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. | Baseline to 28 days after last dose of study drug |
| 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. | Baseline to 28 days after last dose of study drug |
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| Measure | Description | Time Frame |
|---|---|---|
| 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). | Baseline to 28 days after last dose of study drug |
| Number of Participants With Cardiac Arrest- Resuscitated |
Inclusion Criteria:
Exclusion Criteria:
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Patients management of non-ST segment elevated acute coronary syndromes in nursing home who will be treated conservatively (without percutaneous corornary intervention [PCI] or coronary artery bypass graft [CABG] within 48 hours).
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pfizer Investigational Site | Ahmedabad | Gujarat | 380 051 | India | ||
| Pfizer Investigational Site |
Not provided
| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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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. |
| Baseline to 28 days after last dose of study drug |
| 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. | Baseline to 28 days after last dose of study drug |
| Surat |
| Gujarat |
| 395004 |
| India |
| Pfizer Investigational Site | Hisar | Haryana | 125 001 | India |
| Pfizer Investigational Site | Hisar | Haryana | 125005 | India |
| Pfizer Investigational Site | Bangalore | Karnataka | 562114 | India |
| Pfizer Investigational Site | Manglore | Karnataka | 575 018 | India |
| Pfizer Investigational Site | Mysore | Karnataka | 570 020 | India |
| Pfizer Investigational Site | Nagpur | Maharahtra | 440017 | India |
| Pfizer Investigational Site | Nashik | Maharahtra | 3 | India |
| Pfizer Investigational Site | Ambernath (E) | Maharashtra | 421501 | India |
| Pfizer Investigational Site | Nagpur | Maharashtra | 440 001 | India |
| Pfizer Investigational Site | Nagpur | Maharashtra | 440 010 | India |
| Pfizer Investigational Site | Nagpur | Maharashtra | 440012 | India |
| Pfizer Investigational Site | Nagpur | Maharashtra | 440033 | India |
| Pfizer Investigational Site | Nashik | Maharashtra | 422 002 | India |
| Pfizer Investigational Site | Nashik | Maharashtra | 422 009 | India |
| Pfizer Investigational Site | Nashik Road | Maharashtra | 422 002 | India |
| Pfizer Investigational Site | Nashik Road | Maharashtra | 422 101 | India |
| Pfizer Investigational Site | Thane | Maharashtra | India |
| Pfizer Investigational Site | Bikaner | Rajasthan | 334003 | India |
| Pfizer Investigational Site | Jaipur | Rajasthan | 302 012 | India |
| Pfizer Investigational Site | Jaipur | Rajasthan | 302019 | India |
| Pfizer Investigational Site | Chennai | Tamil Nadu | 600 035 | India |
| Pfizer Investigational Site | Kolkata | West Bengal | 700 019 | India |
| COMPLETED |
|
| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Death or Myocardial Infarction (MI) | The full analysis set (FAS) included all enrolled participants who received at least 1 dose of the study medication. | Posted | Number | Participants | Baseline to 28 days after last dose of study drug |
|
|
| |||||||||||||||||||||||||||
| 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. | FAS included all enrolled participants who received at least 1 dose of the study medication. | Posted | Number | Participants | Baseline to 28 days after last dose of study drug |
|
| |||||||||||||||||||||||||||
| 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. | FAS included all enrolled participants who received at least 1 dose of the study medication. | Posted | Number | Participants | Baseline to 28 days after last dose of study drug |
|
| |||||||||||||||||||||||||||
| 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). | FAS included all enrolled participants who received at least 1 dose of the study medication. | Posted | Number | Participants | Baseline to 28 days after last dose of study drug |
|
| |||||||||||||||||||||||||||
| 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. | FAS included all enrolled participants who received at least 1 dose of the study medication. | Posted | Number | Participants | Baseline to 28 days after last dose of study drug |
|
| |||||||||||||||||||||||||||
| 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. | FAS included all enrolled participants who received at least 1 dose of the study medication. | Posted | Number | Participants | Baseline to 28 days after last dose of study drug |
|
|
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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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. | 4 | 617 | 23 | 617 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardiac Arrest | Cardiac disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Cardio-respiratory Arrest | Cardiac disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Left Ventricular Failure | Cardiac disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Pneumonia Aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Abdominal Pain | Gastrointestinal disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Abdominal Pain Lower | Gastrointestinal disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Gingival Bleeding | Gastrointestinal disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Toothache | Gastrointestinal disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Chest Pain | General disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Chills | General disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Hepatitis | Hepatobiliary disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Lower Respiratory Tract Infections | Infections and infestations | MedDRA 13.1 | Non-systematic Assessment |
| |
| Respiratory Rate | Investigations | MedDRA 13.1 | Non-systematic Assessment |
| |
| Back Pain | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Hemiplegia | Nervous system disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Pruritus Generalised | Skin and subcutaneous tissue disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Venous Thrombosis | Vascular disorders | MedDRA 13.1 | Non-systematic Assessment |
|
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer, Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
| ID | Term |
|---|---|
| D054058 | Acute Coronary Syndrome |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
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| ID | Term |
|---|---|
| D017985 | Dalteparin |
| ID | Term |
|---|---|
| D006495 | Heparin, Low-Molecular-Weight |
| D006493 | Heparin |
| D006025 | Glycosaminoglycans |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
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