Atorvastatin Pre-Treatment Study In Asian Patients With Acute Coronary Syndrome

Acute Coronary Syndrome Clinical Trial

— ALPACS  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00728988
• Other study ID #: A2581161
• Status: Completed
• Phase: Phase 4
• Start date: September 2008
• Est. completion date: April 2010

Study information

• Verified date: February 2021
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 499
• Est. completion date: April 2010
• Est. primary completion date: April 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Syndrome

Intervention

Drug:
• Atorvastatin
80mg 12 hours pre-Percutaneous Coronary Intervention (PCI), 40mg 2 hours pre-PCI and 40mg daily after PCI for 30 days.
• Atorvastatin
40mg daily after PCI for 30 days.

Locations

Country	Name	City	State
China	Pfizer Investigational Site	Beijing
China	Pfizer Investigational Site	Beijing
China	Pfizer Investigational Site	Beijing
China	Pfizer Investigational Site	Changsha	Hunan
China	Pfizer Investigational Site	Guangzhou	Guangdong
China	Pfizer Investigational Site	Hangzhou	Zhejiang
China	Pfizer Investigational Site	Qingdao	Shandong
China	Pfizer Investigational Site	Shanghai
China	Pfizer Investigational Site	Shanghai
China	Pfizer Investigational Site	Shanghai
China	Pfizer Investigational Site	Shen Yang	Liaoning
China	Pfizer Investigational Site	Shenyang	Liaoning
Korea, Republic of	Pfizer Investigational Site	Busan
Korea, Republic of	Pfizer Investigational Site	Daegu
Korea, Republic of	Pfizer Investigational Site	Daegu
Korea, Republic of	Pfizer Investigational Site	Daegu
Korea, Republic of	Pfizer Investigational Site	Daejeon
Korea, Republic of	Pfizer Investigational Site	Gangneung-si, Gangwon-do
Korea, Republic of	Pfizer Investigational Site	Gwang Ju
Korea, Republic of	Pfizer Investigational Site	Jinju-si, Gyeongsangnam-do
Korea, Republic of	Pfizer Investigational Site	Koyang-shi
Korea, Republic of	Pfizer Investigational Site	Seongnam-si	Gyeonggi-do, Korea
Korea, Republic of	Pfizer Investigational Site	Seoul
Korea, Republic of	Pfizer Investigational Site	Seoul
Korea, Republic of	Pfizer Investigational Site	Seoul
Korea, Republic of	Pfizer Investigational Site	Ulsan

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Countries where clinical trial is conducted

China,  Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	30 days post PCI
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.	8 hours post PCI
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.	24 hours post PCI
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).	8 hours, 24 hours and 30 days post PCI
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).	8 hours, 24 hours and 30 days post PCI
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).	8 hours, 24 hours and 30 days post PCI
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.	Baseline, 8 hours, 24 hours and 30 days

External Links

•   To obtain contact information for a study center near you, click here.