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Atorvastatin Effectiveness and Safety in Cardiology Patients in Real World Setting (ATTENTION)

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ClinicalTrials.gov Identifier: NCT02565615
Recruitment Status : Active, not recruiting
First Posted : October 1, 2015
Last Update Posted : July 10, 2018
Sponsor:
Information provided by (Responsible Party):
Pfizer

Brief Summary:
The study is to verify atorvastatin effectiveness and safety in Chinese population, and explore the optimal atorvastatin regimens in high-to-moderate risk for ASCVD。

Condition or disease Intervention/treatment
Coronary Artery Disease, Hypercholesterolemia, Hypertension Other: No intervention

Study Type : Observational [Patient Registry]
Estimated Enrollment : 10000 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 12 Weeks
Official Title: Atorvastatin Effectiveness And Safety In Cardiology Patients In Real World Setting: A Registry Study In China
Actual Study Start Date : June 22, 2016
Estimated Primary Completion Date : August 31, 2018
Estimated Study Completion Date : August 31, 2018

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Atorvastatin dose titration (single-arm)
Judged by investigators, patients in cardiology department who are using atorvastatin can be included into this study, if they are eligible. During the study, the dose can be titrated based on the judgement of investigator
Other: No intervention
Because this is a non-interventional study, there is no intervention here.




Primary Outcome Measures :
  1. The proportion of patients who achieve LDL-C goal value at 12-week atorvastatin therapy according to Chinese Guideline on Dyslipidemia Prevention and Treatment in Adult (2007 version). [ Time Frame: 12 weeks ]
    Achievement Rate=No. subjects who achieve LDL-C target value / No. subjects who complete 12-week follow up


Secondary Outcome Measures :
  1. Dosage distribution of atorvastatin in patients within different risk categories as defined by Chinese Guideline on Dyslipidemia Prevention and Treatment in Adult (2007) at the end of 12-weeks [ Time Frame: 12 weeks ]
    calculate the mean dosage of atorvastatin in cardiology patients with different risk stratification at the end of 12-week follow-up

  2. The percentage of patients who dropout and reason [ Time Frame: up to 12 weeks ]
    Dropouts percentage and reason through 12 weeks of follow-up

  3. The proportion of patients who present with muscle related adverse event [ Time Frame: up to 12 weeks ]
    Muscle related adverse event includes symptoms such as myalgia, fatigue, weakness, creatine kinase values 10 times the upper limit of normal, and rhabdomyolysis

  4. The proportion of patients who present with persistent elevation of liver enzyme [ Time Frame: up to 12 weeks ]
    Persistent elevations in Alanine Aminotransferase/ Aspartate Aminotransferase (ALT/AST) >3 Upper Limit of Normal (ULN)

  5. The proportion of patients who present with major adverse cardiovascular events [ Time Frame: up to 12 weeks ]
    MACE includes death from all-cause or cardiac death, myocardial infarction, documented unstable angina requiring re-hospitalization, revascularization with either percutaneous coronary intervention or coronary-artery bypass grafting, stroke



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Chinese cardiology patients
Criteria

Inclusion Criteria:

  • Men and women aged ≥18 years;
  • Cardiology patients who has been prescribed atorvastatin by physician's clinical judgment under normal clinical care. These patients will include those with established coronary heart disease, or having multiple risk factors and at risk for cardiovascular disease, or primary hypercholesterolemia.
  • Baseline laboratory reports prior to starting atorvastatin therapy can be tracked , including lipid measurement, liver function, and Creatine Kinase (CK) value. The date of baseline reports should be within 1 month before taking atorvastatin or within 24h after starting atorvastatin therapy.
  • Evidence of a personally or his/her legally acceptable representative signed and dated informed consent document indicating that the patient has been informed of all pertinent aspects of the study and accept follow-up visit.

Exclusion Criteria:

  • Patients who have regularly taken atorvastatin therapy more than 4 weeks before enrollment
  • Concomitant any other lipid-lower medication at baseline, or during the study conduction on physician clinical judgement

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02565615


  Show 55 Study Locations
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer

Additional Information:
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT02565615     History of Changes
Other Study ID Numbers: A2581197
First Posted: October 1, 2015    Key Record Dates
Last Update Posted: July 10, 2018
Last Verified: July 2018

Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Hypercholesterolemia
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Atorvastatin Calcium
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors