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This present study is specifically designed to examine the efficacy and safety of a high pre-treatment dose of atorvastatin in Asian patients with NSTE-ACS in China and the Republic of Korea, by using a treatment paradigm similar to that employed in the ARMYDA-ACS study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Atorvastatin Group | Experimental |
| |
| Usual Care Group | Other |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Atorvastatin | Drug | 80mg 12 hours pre-Percutaneous Coronary Intervention (PCI), 40mg 2 hours pre-PCI and 40mg daily after PCI for 30 days. |
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| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Major Adverse Cardiac Events (MACE) (Incidence of MACE) at 30 Days Post-percutaneous Coronary Intervention (PCI) | Percentage calculated as: (number of participants who experienced MACE [death, myocardial infarction, target vessel revascularization] within 30 days post-PCI) divided by (number of participants who experienced PCI) * 100. Major Adverse Cardiac Events (MACE) that occurred after 33 days post PCI were excluded. | 30 days post PCI |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Major Adverse Cardiac Events (MACE) (Incidence of MACE) at 8 Hours Post-PCI | Percentage calculated as: (number of participants who experienced MACE within 8 hours post-PCI) divided by (number of participants who experienced PCI) * 100. | 8 hours post PCI |
| Percentage of Participants With Major Adverse Cardiac Events (MACE) (Incidence of MACE) at 24 Hours Post-PCI |
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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 | Guangzhou | Guangdong | 510100 | China | ||
| Pfizer Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24216317 | Derived | Jang Y, Zhu J, Ge J, Kim YJ, Ji C, Lam W. Preloading with atorvastatin before percutaneous coronary intervention in statin-naive Asian patients with non-ST elevation acute coronary syndromes: A randomized study. J Cardiol. 2014 May;63(5):335-43. doi: 10.1016/j.jjcc.2013.09.012. Epub 2013 Nov 9. |
| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Atorvastatin | Atorvastatin 80 mg 12 hours pre- percutaneous coronary intervention (PCI) and 40 mg 2 hours PCI, and usual care. |
| FG001 | Usual Care | Aspirin 200-300 mg pre-PCI and 100-200 mg daily thereafter; clopidogrel 300 mg loading dose at least 3 hours pre-PCI and 75 mg thereafter; subcutaneous heparin: enoxaparin 1 mg/kg every 12 hours pre-PCI or dalteparin 120 IU/kg every 12 hours pre-PCI; and atorvastatin 40 mg daily after PCI for 30 days. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Atorvastatin | Drug | 40mg daily after PCI for 30 days. |
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Percentage calculated as: (number of participants who experienced MACE within 24 hours post PCI) divided by (number of participants who experienced PCI) * 100. |
| 24 hours post PCI |
| Percentage of Participants With Elevated Creatine Kinase-MB (CK-MB) | CK-MB above the upper limit of normal range from baseline (biomarker of myocardial injury); normal range: 0-5.0 nanograms per milliliter (ng/mL). | 8 hours, 24 hours and 30 days post PCI |
| Percentage of Participants With Elevated Troponin I | Troponin I above the upper limit of normal range from baseline (biomarker of myocardial injury): normal range: 0-0.5 nanograms per milliliter (ng/mL). | 8 hours, 24 hours and 30 days post PCI |
| Percentage of Participants With Elevated Myoglobin | Myoglobin above the upper limit of normal from baseline (biomarker of myocardial injury): normal range: 0-109 nanograms per milliliter (ng/mL). | 8 hours, 24 hours and 30 days post PCI |
| Percent Change From Baseline in C-Reactive Protein (CRP) | C-reactive protein percent change from baseline = (post baseline value minus baseline value) divided by baseline value*100. Includes all CRP samples tested for the study, including samples unaffected and those samples affected by defective high-sensitivity (hs) CRP reagents. | Baseline, 8 hours, 24 hours and 30 days |
| Changsha |
| Hunan |
| 410008 |
| China |
| Pfizer Investigational Site | Shenyang | Liaoning | 110004 | China |
| Pfizer Investigational Site | Shenyang | Liaoning | 110016 | China |
| Pfizer Investigational Site | Qingdao | Shandong | 266000 | China |
| Pfizer Investigational Site | Hangzhou | Zhejiang | 310016 | China |
| Pfizer Investigational Site | Beijing | 100029 | China |
| Pfizer Investigational Site | Beijing | 100034 | China |
| Pfizer Investigational Site | Beijing | 100730 | China |
| Pfizer Investigational Site | Shanghai | 200032 | China |
| Pfizer Investigational Site | Shanghai | 200127 | China |
| Pfizer Investigational Site | Shanghai | 200233 | China |
| Pfizer Investigational Site | Seongnam-si | Gyeonggi-do, Korea | 463-707 | South Korea |
| Pfizer Investigational Site | Busan | 602-715 | South Korea |
| Pfizer Investigational Site | Daegu | 705-717 | South Korea |
| Pfizer Investigational Site | Daegu | 705-718 | South Korea |
| Pfizer Investigational Site | Daegu | South Korea |
| Pfizer Investigational Site | Daejeon | 301-721, | South Korea |
| Pfizer Investigational Site | Gangneung-si, Gangwon-do | 210-711 | South Korea |
| Pfizer Investigational Site | Gwangju | 501-757 | South Korea |
| Pfizer Investigational Site | Jinju-si, Gyeongsangnam-do | 660-702 | South Korea |
| Pfizer Investigational Site | Koyang-shi | 410-719 | South Korea |
| Pfizer Investigational Site | Seoul | 130-702 | South Korea |
| Pfizer Investigational Site | Seoul | 152-703 | South Korea |
| Pfizer Investigational Site | Seoul | South Korea |
| Pfizer Investigational Site | Ulsan | 682-714 | South Korea |
| Treated |
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| Full Analysis Set |
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| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Atorvastatin | Atorvastatin 80 mg 12 hours pre- percutaneous coronary intervention (PCI) and 40 mg 2 hours PCI, and usual care. |
| BG001 | Usual Care | Aspirin 200-300 mg pre-PCI and 100-200 mg daily thereafter; clopidogrel 300 mg loading dose at least 3 hours pre-PCI and 75 mg thereafter; subcutaneous heparin: enoxaparin 1 mg/kg every 12 hours pre-PCI or dalteparin 120 IU/kg every 12 hours pre-PCI; and atorvastatin 40 mg daily after PCI for 30 days. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number | participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| 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 With Major Adverse Cardiac Events (MACE) (Incidence of MACE) at 30 Days Post-percutaneous Coronary Intervention (PCI) | Percentage calculated as: (number of participants who experienced MACE [death, myocardial infarction, target vessel revascularization] within 30 days post-PCI) divided by (number of participants who experienced PCI) * 100. Major Adverse Cardiac Events (MACE) that occurred after 33 days post PCI were excluded. | Full Analysis Set (FAS): all participants who received at least one dose of study medication and received percutaneous coronary intervention (PCI). Last observation carried forward (LOCF). | Posted | Number | percentage of participants | 30 days post PCI |
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| Secondary | Percentage of Participants With Major Adverse Cardiac Events (MACE) (Incidence of MACE) at 8 Hours Post-PCI | Percentage calculated as: (number of participants who experienced MACE within 8 hours post-PCI) divided by (number of participants who experienced PCI) * 100. | FAS. | Posted | Number | percentage of participants | 8 hours post PCI |
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| Secondary | Percentage of Participants With Major Adverse Cardiac Events (MACE) (Incidence of MACE) at 24 Hours Post-PCI | Percentage calculated as: (number of participants who experienced MACE within 24 hours post PCI) divided by (number of participants who experienced PCI) * 100. | FAS. | Posted | Number | percentage of participants | 24 hours post PCI |
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| Secondary | Percentage of Participants With Elevated Creatine Kinase-MB (CK-MB) | CK-MB above the upper limit of normal range from baseline (biomarker of myocardial injury); normal range: 0-5.0 nanograms per milliliter (ng/mL). | FAS. N = number of participants with baseline and at least one post-baseline response. | Posted | Number | percentage of participants | 8 hours, 24 hours and 30 days post PCI |
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| Secondary | Percentage of Participants With Elevated Troponin I | Troponin I above the upper limit of normal range from baseline (biomarker of myocardial injury): normal range: 0-0.5 nanograms per milliliter (ng/mL). | FAS. N = number of participants with baseline and at least one post-baseline response. | Posted | Number | percentage of participants | 8 hours, 24 hours and 30 days post PCI |
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| Secondary | Percentage of Participants With Elevated Myoglobin | Myoglobin above the upper limit of normal from baseline (biomarker of myocardial injury): normal range: 0-109 nanograms per milliliter (ng/mL). | FAS. N = number of participants with baseline and at least one post-baseline response. | Posted | Number | percentage of participants | 8 hours, 24 hours and 30 days post PCI |
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| Secondary | Percent Change From Baseline in C-Reactive Protein (CRP) | C-reactive protein percent change from baseline = (post baseline value minus baseline value) divided by baseline value*100. Includes all CRP samples tested for the study, including samples unaffected and those samples affected by defective high-sensitivity (hs) CRP reagents. | FAS. N = number of subjects with non-missing values at baseline. | Posted | Least Squares Mean | Standard Error | percent change in CRP | Baseline, 8 hours, 24 hours and 30 days |
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Safety analysis set: all randomized subjects with at least 1 dose of treatment. An adverse event (AE) term may be reported as both a serious and a non-serious AE, but are distinct events. AE may = serious for 1 subject and non-serious for another subject, or subject may have experienced both a serious and non-serious episode of the same event.
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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 | Atorvastatin | Atorvastatin 80 mg 12 hours pre- percutaneous coronary intervention (PCI) and 40 mg 2 hours PCI, and usual care. | 16 | 245 | 65 | 245 | ||
| EG001 | Usual Care | Aspirin 200-300 mg pre-PCI and 100-200 mg daily thereafter; clopidogrel 300 mg loading dose at least 3 hours pre-PCI and 75 mg thereafter; subcutaneous heparin: enoxaparin 1 mg/kg every 12 hours pre-PCI or dalteparin 120 IU/kg every 12 hours pre-PCI; and atorvastatin 40 mg daily after PCI for 30 days. | 16 | 250 | 45 | 250 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute myocardial infarction | Cardiac disorders | MedDRA 13.0 | Systematic Assessment |
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| Angina unstable | Cardiac disorders | MedDRA 13.0 | Systematic Assessment |
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| Atrial fibrillation | Cardiac disorders | MedDRA 13.0 | Systematic Assessment |
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| Myocardial infarction | Cardiac disorders | MedDRA 13.0 | Systematic Assessment |
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| Palpitations | Cardiac disorders | MedDRA 13.0 | Systematic Assessment |
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| Visual impairment | Eye disorders | MedDRA 13.0 | Systematic Assessment |
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| Gastritis | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
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| Gastritis erosive | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
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| Chest discomfort | General disorders | MedDRA 13.0 | Systematic Assessment |
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| Chest pain | General disorders | MedDRA 13.0 | Systematic Assessment |
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| Death | General disorders | MedDRA 13.0 | Systematic Assessment |
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| Hepatitis acute | Hepatobiliary disorders | MedDRA 13.0 | Systematic Assessment |
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| Post procedural myocardial infarction | Injury, poisoning and procedural complications | MedDRA 13.0 | Systematic Assessment |
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| Alanine aminotransferase increased | Investigations | MedDRA 13.0 | Systematic Assessment |
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| Cerebral infarction | Nervous system disorders | MedDRA 13.0 | Systematic Assessment |
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| Cerebrovascular accident | Nervous system disorders | MedDRA 13.0 | Systematic Assessment |
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| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Myocardial infarction | Cardiac disorders | MedDRA 13.0 | Systematic Assessment |
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| Chest pain | General disorders | MedDRA 13.0 | Systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 13.0 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 13.0 | Systematic Assessment |
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Defective high-sensitivity C reactive protein reagents showed instability and 20% average positive bias in results, affecting only change from baseline in CRP. Analyses were performed on all samples; results include affected and unaffected samples.
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 |
|---|---|
| D000069059 | Atorvastatin |
| ID | Term |
|---|---|
| D011758 | Pyrroles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006538 | Heptanoic Acids |
| D005227 | Fatty Acids |
| D008055 | Lipids |
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| Title | Measurements |
|---|---|
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| >= 65 years |
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| Male |
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| Myocardial Infarction |
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| Target Vessel Revascularization |
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| Death: treatment difference. Null hypothesis = no difference between the incidence rates in two groups. Fisher's exact test was applied because the expected frequency of events was less than 5. | Fisher Exact | 1.0000 | Mean Difference (Final Values) | 0.0 | 2-Sided | 95 | -10.7 | 10.7 | Confidence limits were calculated by the exact unconditional inference. Difference of incidence = usual care minus atorvastatin. | Superiority or Other (legacy) |
| Myocardial Infarction: treatment difference. Null hypothesis = no difference between the incidence rates in the two groups. A 5% two-sided continuity adjusted Chi-square test was applied. | Chi-squared, Corrected | 0.9158 | Mean Difference (Final Values) | 1.0 | 2-Sided | 95 | -7.2 | 9.2 | Difference of incidence = usual care minus atorvastatin. | Superiority or Other (legacy) |
| Unadjusted odds ratio and 95% confidence interval calculated by including treatment group as the only covariate in the logistic regression model. Reference group = usual care. | Regression, Logistic | 0.80 | Odds Ratio (OR) | 0.93 | 2-Sided | 95 | 0.5104 | 1.6846 | Superiority or Other (legacy) |
| Adjusted odds ratio: model includes treatment group and potential confounding covariates age, gender, country, non-ST elevation myocardial infarction, LVEF <=40, and use of beta-blockers, ACE-inhibitors, angiotension receptor blockers, calcium channel antagonists, and diuretics. Reference group = usual care. | Regression, Logistic | 0.90 | Odds Ratio (OR) | 0.96 | 2-Sided | 95 | 0.4887 | 1.8836 | Superiority or Other (legacy) |
| MACE-free survival up to Day 30. A censoring variable with a value of 1 denoted that the subject had the event and 0 indicated that the subject was censored. A log-rank test was applied to investigate any differences on the survival distribution function between two treatment groups. | Log Rank | Survival analysis: Kaplan-Meier log rank test. | 0.8494 | 2-Sided | Superiority or Other (legacy) |
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