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See termination reason in detailed description.
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| Name | Class |
|---|---|
| Bristol-Myers Squibb | INDUSTRY |
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The purpose of this study is to assess the bleeding safety (the composite endpoint of major and clinically relevant non-major bleeding) of 2 doses of apixaban (2.5 mg BID and 5.0 mg BID) or placebo in combination with standard therapy (aspirin and /or additional antiplatelet therapy) over a 24 week treatment period in selected subjects with recent (≤7 days) acute coronary syndrome.
Due to withdraw of global phase 3 study (APPRAISE-2) for safety issue, B0661004 Data monitoring committee (DMC) also recommended terminating this study. Therefore, Pfizer decided to stop this study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Apixaban 2.5 mg | Experimental |
| |
| Apixaban 5.0 mg | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Apixaban | Drug | Apixaban 2.5 mg tablet BID for 24 weeks |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Who Had Composite of International Society on Thrombosis and Haemostasis (ISTH)-Defined Major and Clinically-relevant Non-major (CRNM) Bleeding Events Occurring During the Treatment Period. | Major bleeding event was acute clinically overt bleeding accompanied by decrease in hemoglobin of 2 g/dL or more over a 24-hour period, transfusion of 2 or more units of packed red blood cells, or bleeding that occurs in critical site (e.g., intracranial). Fatal bleeding was also major bleeding event. CRNM bleeding was acute or sub-acute clinically overt bleeding that did not satisfy the criteria for major bleeding and that led to either hospital admission for bleeding, physician guided medical or surgical treatment for bleeding or a change in antithrombotic therapy. | Week 0 to Week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Who Had One or More All Bleeding Occurring During the Treatment Period. | All bleeding included major bleeding (including fatal bleeding), clinically-relevant non-major (CRNM) bleeding, and minor bleeding per international society on thrombosis and haemostasis (ISTH) definitions. | Week 0 to Week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Who Had International Society on Thrombosis and Haemostasis (ISTH)-Defined Individual Bleeding Endpoints (Clinically-relevant Non-major [CRNM] or Minor Bleeding) During the Treatment Period. | ISTH-defined CRNM bleeding was defined as an acute or sub-acute clinically overt bleeding that did not satisfy the criteria for major bleeding and that led to either hospital admission for bleeding, physician guided medical or surgical treatment for bleeding or a change in antithrombotic therapy. ISTH defined minor bleeding event was defined as all acute clinically overt bleeding events not meeting the criteria for either major bleeding or CRNM bleeding were classified as minor bleeding. |
Inclusion Criteria:
Exclusion Criteria:
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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 | Kasuga | Fukuoka | Japan | |||
| Pfizer Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23748920 | Derived | Ogawa H, Goto S, Matsuzaki M, Hiro S, Shima D; APPRAISE-J investigators. Randomized, double-blind trial to evaluate the safety of apixaban with antiplatelet therapy after acute coronary syndrome in Japanese patients (APPRAISE-J). Circ J. 2013;77(9):2341-8. doi: 10.1253/circj.cj-13-0209. Epub 2013 Jun 7. |
| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Placebo was administered twice a day in addition to the standard therapy (aspirin with or without clopidogrel or ticlopidine) for 24 weeks. |
| FG001 | Apixaban 2.5 mg BID |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Apixaban |
| Drug |
Apixaban 5.0 mg tablet BID for 24 weeks |
|
| Placebo | Other | Placebo tablet for 24 weeks |
|
| Percentage of Participants Who Had Major Bleeding Occurring During the Treatment Period Per International Society on Thrombosis and Haemostasis (ISTH) Definitions. |
Major bleeding event was defined as an acute clinically overt bleeding accompanied by decrease in hemoglobin of 2 g/dL or more over a 24-hour period, transfusion of 2 or more units of packed red blood cells, or bleeding that occured in critical site (e.g., intracranial). Fatal bleeding was also major bleeding event. |
| Week 0 to Week 24 |
| Percentage of Participants Who Had Thrombolysis in Myocardial Infarction (TIMI)-Defined Major Bleeding Occurring During the Treatment Period. | TIMI major bleeding event was difined as an intracranial bleeding or clinically overt bleeding (including bleeding evident on imaging studies) associated with a >= 5 gm/dL fall in hemoglobin or a 15% fall in hematocrit from baseline, accounting for the effect of transfusions (1 unit packed red blood cells = 1 gm/dL hemoglobin = 3% hematocrit). | Week 0 to Week 24 |
| Percentage of Participants Who Had Composite of All-cause Death, Non-fatal Myocardial Infarction, Unstable Angina and Stroke During 30 Days After Discontinuation of Therapy. | For 30 days after Week 24 or the discontinuation of study drug |
| Percentage of Participants Who Had Composite of All-cause Death, Non-fatal Myocardial Infarction (MI), Unstable Angina, and Non-hemorrhagic Stroke Occurring During the Intended Treatment Period. | Intended treatment period for efficacy endpoints was defined as a period starting on the day of randomization and ending at the later date of either 2-days after the last dose of study drug or Day 168/Week 24 after randomization day (or the study termination date [19 November 2010, Japan time]). | From the day of randomization to the later date of either 2-days after the last dose of study drug or Day 168/Week 24 after randomization day (or the study termination date [19 November 2010, Japan time]) |
| Week 0 to Week 24 |
| Percentage of Participants Who Had Thrombolysis in Myocardial Infarction (TIMI) Defined-individual Bleeding Endpoints (Minor or Minimal Bleeding) During the Treatment Period. | TIMI minor bleeding event was defined as a clinically overt bleeding (including bleeding evident on imaging studies) associated with a >= 3 gm/dL fall in hemoglobin or a 9% fall in hematocrit from baseline, accounting for the effect of transfusions (1 unit packed red blood cells = 1 gm/dL hemoglobin = 3% hematocrit). TIMI minimal bleeding event was defined as a clinically overt bleeding (including bleeding evident on imaging studies) not meeting criteria for TIMI minor bleeding. | Week 0 to Week 24 |
| Kitakyushu |
| Fukuoka |
| Japan |
| Pfizer Investigational Site | Gifu | Gifu | Japan |
| Pfizer Investigational Site | Hiroshima | Hiroshima | Japan |
| Pfizer Investigational Site | Kure | Hiroshima | Japan |
| Pfizer Investigational Site | Sapporo | Hokkaido | Japan |
| Pfizer Investigational Site | Kumamoto | Kumamoto | Japan |
| Pfizer Investigational Site | Uji | Kyoto | Japan |
| Pfizer Investigational Site | Ikoma | Nara | Japan |
| Pfizer Investigational Site | Hirakata | Osaka | Japan |
| Pfizer Investigational Site | Kawachi-Nagano | Osaka | Japan |
| Pfizer Investigational Site | Matsubara | Osaka | Japan |
| Pfizer Investigational Site | Osaka | Osaka | Japan |
| Pfizer Investigational Site | Yao | Osaka | Japan |
| Pfizer Investigational Site | Wako | Saitama | Japan |
| Pfizer Investigational Site | Sunto | Shizuoka | Japan |
| Pfizer Investigational Site | Minato-Ku | Tokyo | Japan |
| Pfizer Investigational Site | Shinagawa | Tokyo | Japan |
Apixaban 2.5 mg was administered twice a day in addition to the standard therapy (aspirin with or without clopidogrel or ticlopidine) for 24 weeks.
| FG002 | Apixaban 5.0 mg BID | Apixaban 5.0 mg was administered twice a day in addition to the standard therapy (aspirin with or without clopidogrel or ticlopidine) for 24 weeks. |
| Treated Participants |
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| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Placebo was administered twice a day in addition to the standard therapy (aspirin with or without clopidogrel or ticlopidine) for 24 weeks. Number of participants in baseline characteristics means randomized participants. |
| BG001 | Apixaban 2.5 mg BID | 2.5 mg was administered twice a day in addition to the standard therapy (aspirin with or without clopidogrel or ticlopidine) for 24 weeks. Number of participants in baseline characteristics means randomized participants. |
| BG002 | Apixaban 5.0 mg BID | Apixaban 5.0 mg was administered twice a day in addition to the standard therapy (aspirin with or without clopidogrel or ticlopidine) for 24 weeks. Number of participants in baseline characteristics means randomized participants. |
| BG003 | Total | Total of all reporting groups |
| 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 | Percentage of Participants Who Had Composite of International Society on Thrombosis and Haemostasis (ISTH)-Defined Major and Clinically-relevant Non-major (CRNM) Bleeding Events Occurring During the Treatment Period. | Major bleeding event was acute clinically overt bleeding accompanied by decrease in hemoglobin of 2 g/dL or more over a 24-hour period, transfusion of 2 or more units of packed red blood cells, or bleeding that occurs in critical site (e.g., intracranial). Fatal bleeding was also major bleeding event. CRNM bleeding was acute or sub-acute clinically overt bleeding that did not satisfy the criteria for major bleeding and that led to either hospital admission for bleeding, physician guided medical or surgical treatment for bleeding or a change in antithrombotic therapy. | Bleeding endpoint was included in safety evaluations. The safety analysis set was defined as all treated participants (randomized participants who received at least one dose of study drug). | Posted | Number | 95% Confidence Interval | Percentage of Participants | Week 0 to Week 24 |
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| Secondary | Percentage of Participants Who Had One or More All Bleeding Occurring During the Treatment Period. | All bleeding included major bleeding (including fatal bleeding), clinically-relevant non-major (CRNM) bleeding, and minor bleeding per international society on thrombosis and haemostasis (ISTH) definitions. | Bleeding endpoint was included in safety evaluations. The safety analysis set was defined as all treated participants (randomized participants who received at least one dose of study drug). | Posted | Number | 95% Confidence Interval | Percentage of Participants | Week 0 to Week 24 |
| |||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants Who Had Major Bleeding Occurring During the Treatment Period Per International Society on Thrombosis and Haemostasis (ISTH) Definitions. | Major bleeding event was defined as an acute clinically overt bleeding accompanied by decrease in hemoglobin of 2 g/dL or more over a 24-hour period, transfusion of 2 or more units of packed red blood cells, or bleeding that occured in critical site (e.g., intracranial). Fatal bleeding was also major bleeding event. | Bleeding endpoint was included in safety evaluations. The safety analysis set was defined as all treated participants (randomized participants who received at least one dose of study drug). | Posted | Number | 95% Confidence Interval | Percentage of Participants | Week 0 to Week 24 |
| |||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants Who Had Thrombolysis in Myocardial Infarction (TIMI)-Defined Major Bleeding Occurring During the Treatment Period. | TIMI major bleeding event was difined as an intracranial bleeding or clinically overt bleeding (including bleeding evident on imaging studies) associated with a >= 5 gm/dL fall in hemoglobin or a 15% fall in hematocrit from baseline, accounting for the effect of transfusions (1 unit packed red blood cells = 1 gm/dL hemoglobin = 3% hematocrit). | Bleeding endpoint was included in safety evaluations. The safety analysis set was defined as all treated participants (randomized participants who received at least one dose of study drug). | Posted | Number | 95% Confidence Interval | Percentage of Participants | Week 0 to Week 24 |
| |||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants Who Had Composite of All-cause Death, Non-fatal Myocardial Infarction, Unstable Angina and Stroke During 30 Days After Discontinuation of Therapy. | Bleeding endpoint was included in safety evaluations. The safety analysis set was defined as all treated participants (randomized participants who received at least one dose of study drug). | Posted | Number | 95% Confidence Interval | Percentage of Participants | For 30 days after Week 24 or the discontinuation of study drug |
| ||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants Who Had Composite of All-cause Death, Non-fatal Myocardial Infarction (MI), Unstable Angina, and Non-hemorrhagic Stroke Occurring During the Intended Treatment Period. | Intended treatment period for efficacy endpoints was defined as a period starting on the day of randomization and ending at the later date of either 2-days after the last dose of study drug or Day 168/Week 24 after randomization day (or the study termination date [19 November 2010, Japan time]). | The efficacy analysis set was all randomized participants. | Posted | Number | 95% Confidence Interval | Percentage of Participants | From the day of randomization to the later date of either 2-days after the last dose of study drug or Day 168/Week 24 after randomization day (or the study termination date [19 November 2010, Japan time]) |
| |||||||||||||||||||||||||||||||||
| Other Pre-specified | Percentage of Participants Who Had International Society on Thrombosis and Haemostasis (ISTH)-Defined Individual Bleeding Endpoints (Clinically-relevant Non-major [CRNM] or Minor Bleeding) During the Treatment Period. | ISTH-defined CRNM bleeding was defined as an acute or sub-acute clinically overt bleeding that did not satisfy the criteria for major bleeding and that led to either hospital admission for bleeding, physician guided medical or surgical treatment for bleeding or a change in antithrombotic therapy. ISTH defined minor bleeding event was defined as all acute clinically overt bleeding events not meeting the criteria for either major bleeding or CRNM bleeding were classified as minor bleeding. | Bleeding endpoint was included in safety evaluations. The safety analysis set was defined as all treated participants (randomized participants who received at least one dose of study drug). | Posted | Number | 95% Confidence Interval | Percentage of Participants | Week 0 to Week 24 |
| |||||||||||||||||||||||||||||||||
| Other Pre-specified | Percentage of Participants Who Had Thrombolysis in Myocardial Infarction (TIMI) Defined-individual Bleeding Endpoints (Minor or Minimal Bleeding) During the Treatment Period. | TIMI minor bleeding event was defined as a clinically overt bleeding (including bleeding evident on imaging studies) associated with a >= 3 gm/dL fall in hemoglobin or a 9% fall in hematocrit from baseline, accounting for the effect of transfusions (1 unit packed red blood cells = 1 gm/dL hemoglobin = 3% hematocrit). TIMI minimal bleeding event was defined as a clinically overt bleeding (including bleeding evident on imaging studies) not meeting criteria for TIMI minor bleeding. | Bleeding endpoint was included in safety evaluations. The safety analysis set was defined as all treated participants (randomized participants who received at least one dose of study drug). | Posted | Number | 95% Confidence Interval | Percentage of Participants | Week 0 to Week 24 |
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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 | Placebo | Placebo was administered twice a day in addition to the standard therapy (aspirin with or without clopidogrel or ticlopidine) for 24 weeks. | 8 | 51 | 22 | 51 | ||
| EG001 | Apixaban 2.5 mg BID | Apixaban 2.5 mg was administered twice a day in addition to the standard therapy (aspirin with or without clopidogrel or ticlopidine) for 24 weeks. | 11 | 49 | 28 | 49 | ||
| EG002 | Apixaban 5.0 mg BID | Apixaban 5.0 mg was administered twice a day in addition to the standard therapy (aspirin with or without clopidogrel or ticlopidine) for 24 weeks. | 7 | 49 | 22 | 49 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Angina pectoris | Cardiac disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Angina unstable | Cardiac disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Arteriospasm coronary | Cardiac disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Cardiac failure | Cardiac disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Coronary artery occlusion | Cardiac disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Cataract | Eye disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Pterygium | Eye disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Diverticulum intestinal haemorrhagic | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Lower gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Oesophageal ulcer | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Upper gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Feeling abnormal | General disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Sudden cardiac death | General disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Diverticulitis | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
| |
| Lung abscess | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
| |
| Arterial restenosis | Injury, poisoning and procedural complications | MedDRA 13.1 | Systematic Assessment |
| |
| Coronary artery restenosis | Injury, poisoning and procedural complications | MedDRA 13.1 | Systematic Assessment |
| |
| Overdose | Injury, poisoning and procedural complications | MedDRA 13.1 | Systematic Assessment |
| |
| Road traffic accident | Injury, poisoning and procedural complications | MedDRA 13.1 | Systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Colon cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 13.1 | Systematic Assessment |
| |
| Rectal cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 13.1 | Systematic Assessment |
| |
| Cerebral infarction | Nervous system disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Interstitial lung disease | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Systematic Assessment |
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| Urticaria | Skin and subcutaneous tissue disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Arteriosclerosis obliterans | Vascular disorders | MedDRA 13.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Gingival bleeding | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
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| Chest discomfort | General disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA 13.1 | Systematic Assessment |
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| Post procedural haemorrhage | Injury, poisoning and procedural complications | MedDRA 13.1 | Systematic Assessment |
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| Blood urine present | Investigations | MedDRA 13.1 | Systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA 13.1 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 13.1 | Systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Systematic Assessment |
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| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Systematic Assessment |
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| Haemorrhage subcutaneous | Skin and subcutaneous tissue disorders | MedDRA 13.1 | Systematic Assessment |
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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 |
|---|---|
| C522181 | apixaban |
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| Male |
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| Units | Counts |
|---|---|
| Participants |
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| Units |
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| Counts |
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| Participants |
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Apixaban 5.0 mg was administered twice a day in addition to the standard therapy (aspirin with or without clopidogrel or ticlopidine) for 24 weeks.
|
|
| Apixaban 5.0 mg BID |
Apixaban 5.0 mg was administered twice a day in addition to the standard therapy (aspirin with or without clopidogrel or ticlopidine) for 24 weeks. |
|
|
| Apixaban 5.0 mg BID |
Apixaban 5.0 mg was administered twice a day in addition to the standard therapy (aspirin with or without clopidogrel or ticlopidine) for 24 weeks. |
|
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