NCT00728988

Brief 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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
499

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Sep 2008

Geographic Reach
2 countries

26 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 31, 2008

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 6, 2008

Completed
26 days until next milestone

Study Start

First participant enrolled

September 1, 2008

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2010

Completed
1.5 years until next milestone

Results Posted

Study results publicly available

September 27, 2011

Completed
Last Updated

February 21, 2021

Status Verified

February 1, 2021

Enrollment Period

1.6 years

First QC Date

July 31, 2008

Results QC Date

April 25, 2011

Last Update Submit

February 17, 2021

Conditions

Acute Coronary Syndrome

Keywords

Asia Lipitor Pre-treatment in Acute Coronary Syndrome

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (6)

  • Percentage of Participants With Major Adverse Cardiac Events (MACE) (Incidence of MACE) at 8 Hours Post-PCI

    8 hours post PCI

  • Percentage of Participants With Major Adverse Cardiac Events (MACE) (Incidence of MACE) at 24 Hours Post-PCI

    24 hours post PCI

  • Percentage of Participants With Elevated Creatine Kinase-MB (CK-MB)

    8 hours, 24 hours and 30 days post PCI

  • Percentage of Participants With Elevated Troponin I

    8 hours, 24 hours and 30 days post PCI

  • Percentage of Participants With Elevated Myoglobin

    8 hours, 24 hours and 30 days post PCI

  • +1 more secondary outcomes

Study Arms (2)

Atorvastatin Group

EXPERIMENTAL
Drug: Atorvastatin

Usual Care Group

OTHER
Drug: Atorvastatin

Interventions

AtorvastatinDRUG

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

Atorvastatin Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Non-ST elevated ACS; LDL-C \> 80 mg/dl

You may not qualify if:

  • ST elevated acute myocardial infarction; previously or currently treated with atorvastatin or other statins

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (26)

Pfizer Investigational Site

Guangzhou, Guangdong, 510100, China

Location

Pfizer Investigational Site

Changsha, Hunan, 410008, China

Location

Pfizer Investigational Site

Shenyang, Liaoning, 110004, China

Location

Pfizer Investigational Site

Shenyang, Liaoning, 110016, China

Location

Pfizer Investigational Site

Qingdao, Shandong, 266000, China

Location

Pfizer Investigational Site

Hangzhou, Zhejiang, 310016, China

Location

Pfizer Investigational Site

Beijing, 100029, China

Location

Pfizer Investigational Site

Beijing, 100034, China

Location

Pfizer Investigational Site

Beijing, 100730, China

Location

Pfizer Investigational Site

Shanghai, 200032, China

Location

Pfizer Investigational Site

Shanghai, 200127, China

Location

Pfizer Investigational Site

Shanghai, 200233, China

Location

Pfizer Investigational Site

Seongnam-si, Gyeonggi-do, Korea, 463-707, South Korea

Location

Pfizer Investigational Site

Busan, 602-715, South Korea

Location

Pfizer Investigational Site

Daegu, 705-717, South Korea

Location

Pfizer Investigational Site

Daegu, 705-718, South Korea

Location

Pfizer Investigational Site

Daegu, South Korea

Location

Pfizer Investigational Site

Daejeon, 301-721,, South Korea

Location

Pfizer Investigational Site

Gangneung-si, Gangwon-do, 210-711, South Korea

Location

Pfizer Investigational Site

Gwangju, 501-757, South Korea

Location

Pfizer Investigational Site

Jinju-si, Gyeongsangnam-do, 660-702, South Korea

Location

Pfizer Investigational Site

Koyang-shi, 410-719, South Korea

Location

Pfizer Investigational Site

Seoul, 130-702, South Korea

Location

Pfizer Investigational Site

Seoul, 152-703, South Korea

Location

Pfizer Investigational Site

Seoul, South Korea

Location

Pfizer Investigational Site

Ulsan, 682-714, South Korea

Location

Related Publications (1)

  • 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.

    PMID: 24216317DERIVED

Related Links

MeSH Terms

Conditions

Acute Coronary Syndrome

Interventions

Atorvastatin

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular Diseases

Intervention Hierarchy (Ancestors)

PyrrolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeptanoic AcidsFatty AcidsLipids

Limitations and Caveats

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.

Results Point of Contact

Title
Pfizer ClinicalTrials.gov Call Center
Organization
Pfizer, Inc.
ClinicalTrials.gov_Inquiries@pfizer.com
1-800-718-1021

Study Officials

  • Pfizer CT.gov Call Center

    Pfizer

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 31, 2008

First Posted

August 6, 2008

Study Start

September 1, 2008

Primary Completion

April 1, 2010

Study Completion

April 1, 2010

Last Updated

February 21, 2021

Results First Posted

September 27, 2011

Record last verified: 2021-02

Locations

CN(12)KR(14)