Acute Coronary SyndromePhase 4ALPACSNCT00728988

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

A Phase 4 study testing Atorvastatin in people with Acute Coronary Syndrome, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. at 26 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Acute Coronary Syndrome
What is being tested?: Atorvastatin
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 499 participants
Where: 26 sitesin 2 countries
Study dates: Sep 2008to Apr 2010
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

26 sites in 2 countries.

Country

City, postcode or hospital

26 sites in 2 countries

South Korea14 sites

Pfizer Investigational Site
Busan, 602-715
Pfizer Investigational Site
Daegu, 705-717
Pfizer Investigational Site
Daegu, 705-718
Pfizer Investigational Site
Daegu
Pfizer Investigational Site
Daejeon, 301-721,
Pfizer Investigational Site
Gangneung-si, Gangwon-do, 210-711
Pfizer Investigational Site
Gwangju, 501-757
Pfizer Investigational Site
Jinju-si, Gyeongsangnam-do, 660-702
Pfizer Investigational Site
Koyang-shi, 410-719
Pfizer Investigational Site
Seongnam-si, Gyeonggi-do, Korea, 463-707
Pfizer Investigational Site
Seoul, 130-702
Pfizer Investigational Site
Seoul, 152-703
Pfizer Investigational Site
Seoul
Pfizer Investigational Site
Ulsan, 682-714

Other trials in South Korea

China12 sites

Pfizer Investigational Site
Beijing, 100029
Pfizer Investigational Site
Beijing, 100034
Pfizer Investigational Site
Beijing, 100730
Pfizer Investigational Site
Changsha, Hunan, 410008
Pfizer Investigational Site
Guangzhou, Guangdong, 510100
Pfizer Investigational Site
Hangzhou, Zhejiang, 310016
Pfizer Investigational Site
Qingdao, Shandong, 266000
Pfizer Investigational Site
Shanghai, 200032
Pfizer Investigational Site
Shanghai, 200127
Pfizer Investigational Site
Shanghai, 200233
Pfizer Investigational Site
Shenyang, Liaoning, 110004
Pfizer Investigational Site
Shenyang, Liaoning, 110016

Other trials in China

About this study

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

Conditions: Acute Coronary Syndrome
Being tested: Atorvastatin
Keywords: Asia Lipitor Pre-treatment in Acute Coronary Syndrome
Medical subject headings: Acute Coronary Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

Study groups in NCT00728988
Study group	Role	What they receive
Atorvastatin Group	Experimental	Not described Receives: Drug: Atorvastatin
Usual Care Group	Other	Not described Receives: Drug: Atorvastatin

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 30 days post PCI

Secondary outcomes (6)

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.
Measured: 8 hours post PCI
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.
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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.
Measured: Baseline, 8 hours, 24 hours and 30 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Sep 2008Apr 2010

First posted6 Aug 2008 (estimated)
Study startSep 2008
Primary completionApr 2010
Study completionApr 2010

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Acute Coronary SyndromeStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 499 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00728988
Sponsor's protocol ID: A2581161
Acronym: ALPACS
Status last verified: Feb 2021
First submitted: 31 Jul 2008
Last updated: 21 Feb 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

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.
PubMed 24216317

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 21 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT00728988
Acronym / sponsor ID: ALPACS / A2581161
Conditions: Acute Coronary Syndrome
Keywords: Asia Lipitor Pre-treatment in Acute Coronary Syndrome
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 499 participants (actual)
Lead sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.Industry (pharma, biotech, devices)
Study start: Sep 2008
Primary completion: Apr 2010 (actual)
Study completion: Apr 2010 (actual)
First posted: 6 Aug 2008 (estimated)
Results: Posted 27 Sep 2011

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Atorvastatin Group	Experimental	Drug: Atorvastatin
Usual Care Group	Other	Drug: Atorvastatin

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

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

Key exclusion criteria (1 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Atorvastatin80mg 12 hours pre-Percutaneous Coronary Intervention (PCI), 40mg 2 hours pre-PCI and 40mg daily after PCI for 30 days.	Drug	Atorvastatin Group
Atorvastatin40mg daily after PCI for 30 days.	Drug	Usual Care Group

Primary outcome

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
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.

6 secondary outcomes

Percentage of Participants With Major Adverse Cardiac Events (MACE) (Incidence of MACE) at 8 Hours Post-PCI
Time frame: 8 hours post PCI
Percentage of Participants With Major Adverse Cardiac Events (MACE) (Incidence of MACE) at 24 Hours Post-PCI
Time frame: 24 hours post PCI
Percentage of Participants With Elevated Creatine Kinase-MB (CK-MB)
Time frame: 8 hours, 24 hours and 30 days post PCI
Percentage of Participants With Elevated Troponin I
Time frame: 8 hours, 24 hours and 30 days post PCI
Percentage of Participants With Elevated Myoglobin
Time frame: 8 hours, 24 hours and 30 days post PCI
Percent Change From Baseline in C-Reactive Protein (CRP)
Time frame: Baseline, 8 hours, 24 hours and 30 days

Results and safety

Results posted to the registry on 27 Sep 2011, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Atorvastatin	247	154
Usual Care	252	164

Primary outcome: 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. Number. Unit: percentage of participants

Measure	Atorvastatin n = 163	Usual Care n = 172
Total MACE	14.7	15.7
Death	0.6	0.6
Myocardial Infarction	14.1	15.1
Target Vessel Revascularization	0.0	0.0

Atorvastatin vs Usual Care: Mean Difference (Final Values): 1.0 (95% CI -7.3 to 9.3), p = 0.9237, Chi-squared, Corrected
Atorvastatin vs Usual Care: Mean Difference (Final Values): 0.0 (95% CI -10.7 to 10.7), p = 1.0000, Fisher Exact
Atorvastatin vs Usual Care: Mean Difference (Final Values): 1.0 (95% CI -7.2 to 9.2), p = 0.9158, Chi-squared, Corrected

Population analysed: 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).

6 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Atorvastatin	16 of 245 (6.5%)	65 of 245 (26.5%)	Not reported
Usual Care	16 of 250 (6.4%)	45 of 250 (18%)	Not reported

Limitations and caveats (from the sponsor): 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.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 24216317Jang 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.
To obtain contact information for a study center near you, click here.Link provided by the sponsor.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Pfizer CT.gov Call Center study director

Pfizer

26 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Atorvastatin in people with Acute Coronary Syndrome, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. at 26 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 26 sites in South Korea, China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 27 Sep 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00728988, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Feb 2021.