Atorvastatin Pre-Treatment Study In Asian Patients With Acute Coronary Syndrome (ALPACS)
This study has been completed.
Sponsor:
Pfizer
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00728988
First received: July 31, 2008
Last updated: September 29, 2011
Last verified: September 2011
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Acute Coronary Syndrome |
Drug: Atorvastatin |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention |
| Official Title: | A Prospective Randomized, Open-Label, Parallel-Group Comparative Study: Atorvastatin Pre-Treatment Versus Usual Care In Asian Patients With Acute Coronary Syndromes Undergoing Early Percutaneous Coronary Intervention |
Resource links provided by NLM:
Further study details as provided by Pfizer:
Primary Outcome Measures:
- Percentage of Participants With Major Adverse Cardiac Events (MACE) (Incidence of MACE) at 30 Days Post-percutaneous Coronary Intervention (PCI) [ Time Frame: 30 days post PCI ] [ Designated as safety issue: No ]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.
Secondary Outcome Measures:
- Percentage of Participants With Major Adverse Cardiac Events (MACE) (Incidence of MACE) at 8 Hours Post-PCI [ Time Frame: 8 hours post PCI ] [ Designated as safety issue: No ]Percentage calculated as: (number of participants who experienced MACE within 8 hours post-PCI) divided by (number of participants who experienced PCI) * 100.
- Percentage of Participants With Major Adverse Cardiac Events (MACE) (Incidence of MACE) at 24 Hours Post-PCI [ Time Frame: 24 hours post PCI ] [ Designated as safety issue: No ]Percentage calculated as: (number of participants who experienced MACE within 24 hours post PCI) divided by (number of participants who experienced PCI) * 100.
- Percentage of Participants With Elevated Creatine Kinase-MB (CK-MB) [ Time Frame: 8 hours, 24 hours and 30 days post PCI ] [ Designated as safety issue: No ]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).
- Percentage of Participants With Elevated Troponin I [ Time Frame: 8 hours, 24 hours and 30 days post PCI ] [ Designated as safety issue: No ]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).
- Percentage of Participants With Elevated Myoglobin [ Time Frame: 8 hours, 24 hours and 30 days post PCI ] [ Designated as safety issue: No ]Myoglobin above the upper limit of normal from baseline (biomarker of myocardial injury): normal range: 0-109 nanograms per milliliter (ng/mL).
- Percent Change From Baseline in C-Reactive Protein (CRP) [ Time Frame: Baseline, 8 hours, 24 hours and 30 days ] [ Designated as safety issue: No ]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.
| Enrollment: | 499 |
| Study Start Date: | September 2008 |
| Study Completion Date: | April 2010 |
| Primary Completion Date: | April 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Atorvastatin Group |
Drug: Atorvastatin
80mg 12 hours pre-Percutaneous Coronary Intervention (PCI), 40mg 2 hours pre-PCI and 40mg daily after PCI for 30 days.
|
| Usual Care Group |
Drug: Atorvastatin
40mg daily after PCI for 30 days.
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Non-ST elevated ACS; LDL-C > 80 mg/dl
Exclusion Criteria:
- ST elevated acute myocardial infarction; previously or currently treated with atorvastatin or other statins
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00728988
Locations
| China, Guangdong | |
| Pfizer Investigational Site | |
| Guangzhou, Guangdong, China, 510100 | |
| China, Hunan | |
| Pfizer Investigational Site | |
| Changsha, Hunan, China, 410008 | |
| China, Liaoning | |
| Pfizer Investigational Site | |
| Shen Yang, Liaoning, China, 110016 | |
| Pfizer Investigational Site | |
| Shenyang, Liaoning, China, 110004 | |
| China, Shandong | |
| Pfizer Investigational Site | |
| Qingdao, Shandong, China, 266000 | |
| China, Zhejiang | |
| Pfizer Investigational Site | |
| Hangzhou, Zhejiang, China, 310016 | |
| China | |
| Pfizer Investigational Site | |
| Beijing, China, 100730 | |
| Pfizer Investigational Site | |
| Beijing, China, 100034 | |
| Pfizer Investigational Site | |
| Beijing, China, 100029 | |
| Pfizer Investigational Site | |
| Shanghai, China, 200233 | |
| Pfizer Investigational Site | |
| Shanghai, China, 200127 | |
| Pfizer Investigational Site | |
| Shanghai, China, 200032 | |
| Korea, Republic of | |
| Pfizer Investigational Site | |
| Seongnam-si, Gyeonggi-do, Korea, Korea, Republic of, 463-707 | |
| Pfizer Investigational Site | |
| Busan, Korea, Republic of, 602-715 | |
| Pfizer Investigational Site | |
| Daegu, Korea, Republic of, 705-717 | |
| Pfizer Investigational Site | |
| Daegu, Korea, Republic of, 705-718 | |
| Pfizer Investigational Site | |
| Daegu, Korea, Republic of | |
| Pfizer Investigational Site | |
| Daejeon, Korea, Republic of, 301-721, | |
| Pfizer Investigational Site | |
| Gangneung-si, Gangwon-do, Korea, Republic of, 210-711 | |
| Pfizer Investigational Site | |
| Gwang Ju, Korea, Republic of, 501-757 | |
| Pfizer Investigational Site | |
| Jinju-si, Gyeongsangnam-do, Korea, Republic of, 660-702 | |
| Pfizer Investigational Site | |
| Koyang-shi, Korea, Republic of, 410-719 | |
| Pfizer Investigational Site | |
| Seoul, Korea, Republic of | |
| Pfizer Investigational Site | |
| Seoul, Korea, Republic of, 130-702 | |
| Pfizer Investigational Site | |
| Seoul, Korea, Republic of, 152-703 | |
| Pfizer Investigational Site | |
| Ulsan, Korea, Republic of, 682-714 | |
Sponsors and Collaborators
Pfizer
Investigators
| Study Director: | Pfizer CT.gov Call Center | Pfizer |
More Information
Additional Information:
No publications provided
| Responsible Party: | Pfizer |
| ClinicalTrials.gov Identifier: | NCT00728988 History of Changes |
| Other Study ID Numbers: | A2581161 |
| Study First Received: | July 31, 2008 |
| Results First Received: | April 25, 2011 |
| Last Updated: | September 29, 2011 |
| Health Authority: | Korea: Food and Drug Administration |
Keywords provided by Pfizer:
|
Asia Lipitor Pre-treatment in Acute Coronary Syndrome |
Additional relevant MeSH terms:
|
Acute Coronary Syndrome Myocardial Ischemia Heart Diseases Cardiovascular Diseases Angina Pectoris Vascular Diseases Chest Pain Pain Signs and Symptoms Atorvastatin |
Hydroxymethylglutaryl-CoA Reductase Inhibitors Anticholesteremic Agents Hypolipidemic Agents Antimetabolites Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Enzyme Inhibitors Lipid Regulating Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 22, 2013