UMIN-CTR Clinical Trial

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

Acute coronary syndrome

Classification by specialty

Cardiology

Classification by malignancy

Others

Genomic information

NO

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

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

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

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

Institute

Sanofi K.K.

Institute

Department

Personal name

Organization

Sanofi K.K.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2008

Year

05

Month

10

Day

URL releasing protocol

Publication of results

Unpublished

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

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 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

Registered date

2008

Year

04

Month

23

Day

Last modified on

2012

Year

10

Month

23

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001375