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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000001128
Receipt No. R000001375
Scientific Title A prospective observation study concerning the incidence of atherothrombotic events in patients with acute coronary syndrome.
Date of disclosure of the study information 2008/05/10
Last modified on 2012/10/23

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Basic information
Public title A prospective observation study concerning the incidence of atherothrombotic events in patients with acute coronary syndrome.
Acronym Prevention of atherothrombotic incidents following ischemic coronary attack (PACIFIC) Registry
Scientific Title A prospective observation study concerning the incidence of atherothrombotic events in patients with acute coronary syndrome.
Scientific Title:Acronym Prevention of atherothrombotic incidents following ischemic coronary attack (PACIFIC) Registry
Region
Japan

Condition
Condition Acute coronary syndrome
Classification by specialty
Cardiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 In the Japanese patients with acute coronary syndrome, the incidence of atherothrombotic events (coronary artery disease, cerebrovascular disease and peripheral arterial disease) from baseline to 2 years will be analyzed.
Basic objectives2 Others
Basic objectives -Others To evaluate the incidence of cardiovascular events in patient subgroups (e.g.: metabolic syndrome, diabetes mellitus, hypertension, hyperlipidemia) and compare outcomes.
Trial characteristics_1
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes The incidence of major adverse cardiovascular /cerebrovascular events (MACCE), including vascular death, MI, stroke since baseline to 2 years.
Key secondary outcomes The incidence of the primary endpoint and each following event are evaluated and the differences of each high-risk patient sub-group are examined.
A) Death due to MI
B) Death due to stroke
C) Other cardiovascular death
D) Non-cardiovascular death
E) Non-fatal MI, unstable angina
F) Non-fatal stroke
G) Acute arterial occlusion
H) Central retinal artery occlusion
I) Coronary revascularization due to myocardial ischemia
J) Hospitalization due to HF
K) Hospitalization due to TIA
L) Hospitalization due to revascularization
M) Hemorrhages requiring hospitalization or blood transfusion
N) Other adverse events requiring hospitalization
O) Target Vessel Failure

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Inpatients with ACS below:
1) Acute ST-segment elevation myocardial infarction
2) Acute non-ST-segment elevation myocardial infarction
3) Unstable angina pectoris
Key exclusion criteria Patients meeting any of the following criteria will be excluded from the study.
1) Chest pain and coronary diseases developed in association with other serious diseases or their treatments (e.g.: myocardial infarctions associated with car accidents, traumas, serious gastrointestinal hemorrhage or associated with vascular intervention or coronary bypass surgery)
2) Inpatients not intended for close examination/treatment of chest pain
3) Patients who are sub acute stent-thrombosis
4) Patients aged less than 20 years
5) Patients not providing a written consent by themselves or their family members
6) Patients who are disqualified the study by the investigators
Target sample size 4000

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hiroyuki Daida
Organization Juntendo University
Division name Division of Cardiology, Department of Internal Medicine
Zip code
Address 2-1-1, Hongo, Bunkyo-Ku, Tokyo, 113-8421, Japan
TEL 03-3813-3111
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization PACIFIC Helpdesk
Division name Mebix Inc.
Zip code
Address
TEL 0120-303-806
Homepage URL
Email PACIFIC-HD@mebix.co.jp

Sponsor
Institute Sanofi K.K.
Institute
Department

Funding Source
Organization Sanofi K.K.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2008 Year 05 Month 10 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status No longer recruiting
Date of protocol fixation
2007 Year 12 Month 31 Day
Date of IRB
Anticipated trial start date
2008 Year 05 Month 01 Day
Last follow-up date
2011 Year 09 Month 01 Day
Date of closure to data entry
2011 Year 09 Month 01 Day
Date trial data considered complete
2011 Year 09 Month 01 Day
Date analysis concluded

Other
Other related information Observation Items

Registration
1.Patient background
Demographic information (date of birth, age (automatic calculation), sex)
2. Ongoing or previous history of ischemic cardiac diseases, ischemic apoplexy or peripheral arterial diseases or a previous history of vascular intervention
3. Ongoing or previous history of other diseases (diabetes, hypertension, dyslipidemia, hemodialysis)
4. Smoking status/ Drinking status
5. Drug therapies at present
6. Physical examinations (body height, body weight, waist size, blood pressure, heart rate (arrhythmia/ RSA), shock, BMI, carotid stenosis, ABI
7. Biochemical examinations (blood glucose, HbA1c, fasting TG, HDL-cholesterol, total cholesterol, LDL-cholesterol, CPK Max, CPK-MB, CRP, BNP, creatinine, hemoglobin, hematocrit, gamma-GTP,AST)
8. Pathology of ACS and treatment in the acute stage (characterize of ACS, culprit vessel, number of vessels with stenosis, Killip's classification, ejection fraction)

At discharge
1. Date of discharge
2. Treatment of ACS in the hospital
A) PCI (operation date, % stenosis, TIMI flow, success/failure, complication, POBA/stent<type/number>)
B) CABG (operation date, on-pump-CAB/OPCAB/MIDCAB, number of bypass, Type of graft, patency assessment
C) Drug therapies at acute phase/at discharge
3.Primary/ secondary endpoints

1-year and 2-year follow-up
1.Date of follow-up
2.Primary/ secondary endpoints
3.Other outcomes (hemorrhages requiring hospitalization or blood transfusion, Other adverse events requiring hospitalization)
4.Physical examinations (body height, body weight, waist size, blood pressure, heart rate (arrhythmia/ RSA),ABI, carotid stenosis, smoking status/drinking status)
5.Biochemical examinations (fasting blood glucose, HbA1c, fasting TG, HDL-cholesterol, total cholesterol, LDL-cholesterol, CPK, BNP, creatinine, hemoglobin, hematocrit, gamma-GTP,AST)
6.Drug therapy at follow-up

Management information
Registered date
2008 Year 04 Month 23 Day
Last modified on
2012 Year 10 Month 23 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001375

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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