UMIN-CTR Clinical Trial

Public title

Appropriate Dose of Initial Heparin Administration without Glycoprotein Inhibitor on Catheter Intervention

Acronym

Appropriate Dose of Initial Heparin Administration on Catheter Intervention

Scientific Title

Appropriate Dose of Initial Heparin Administration without Glycoprotein Inhibitor on Catheter Intervention

Scientific Title:Acronym

Appropriate Dose of Initial Heparin Administration on Catheter Intervention

Region

Japan

Condition

Coronary/peripheral artery disease planned with catheter intervention

Classification by specialty

Cardiology

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

Clinical trials in 1990's reported that activated clotting time (ACT) of 200 to 250 seconds under administration of glycoprotein IIb/IIIa inhibitor (GPI) appeared to be reasonable in terms of safety and efficacy during coronary angioplasty. However, there was few report about ACT kinetics in their procedures without GPI, and also appropriate amount of initial bolus injection of heparin was under discussion. Based on those backgrounds, we ought to evaluate relationship between initial dose of unfractionated heparin and bleeding/embolic complications.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

i) Time achieved with ACT>250 seconds
ii) Bleeding and embolic complications up to 30 days after the procedure

Key secondary outcomes

i) Frequency of heparin addition during procedure
ii) Change of WBC/RBC/Platelets between before and after the procedure
iii) All-cause death, MACE

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Dose comparison

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

4

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Patients for staged catheter intervention on coronary and peripheral vessels were administered with 30 IU/kg of initial bolus unfractionated heparin. ACT is tested before and every 30 minutes after initial bolus, and 2,000 IU of additional heparin is administered if ACT is less than 250 seconds.

Interventions/Control_2

Patients for staged catheter intervention on coronary and peripheral vessels were administered with 50 IU/kg of initial bolus unfractionated heparin. ACT is tested before and every 30 minutes after initial bolus, and 2,000 IU of additional heparin is administered if ACT is less than 250 seconds.

Interventions/Control_3

Patients for staged catheter intervention on coronary and peripheral vessels were administered with 100 IU/kg of initial bolus unfractionated heparin. ACT is tested before and every 30 minutes after initial bolus, and 2,000 IU of additional heparin is administered if ACT is less than 250 seconds.

Interventions/Control_4

Patients for staged catheter intervention on coronary and peripheral vessels were administered with 150 IU/kg of initial bolus unfractionated heparin. ACT is tested before and every 30 minutes after initial bolus, and 2,000 IU of additional heparin is administered if ACT is less than 250 seconds.

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

Patients for coronary or peripheral vessel intervention with informed consent, and without predicted demerit on heparin use.

Key exclusion criteria

i) Emergent/urgent intervention
ii) Patients with malignant neoplasm whose life expectancies of less than 6 months
iii) Patients with active bleeding or embolic complications
iv) Patients with HIT(Heparin-Induced Thrombocytopenia)
v) Unsuitable patients for this trial judged by doctor-in-charge

Target sample size

160

Name of lead principal investigator

1st name
Middle name
Last name	Kentaro Jujo

Organization

Nishiarai Heart Center Hospital

Division name

Department of Cardiology

Zip code

Address

1-12-8, Nishiarai Honcho, Adachi-ku, Tokyo, Japan

TEL

+81358380730

Email

juken1123@hotmail.co.jp

Name of contact person

1st name
Middle name
Last name	Kentaro Jujo

Organization

Nishiarai Heart Center Hospital

Division name

Department of Cardiology

Zip code

Address

1-12-8, Nishiarai Honcho, Adachi-ku, Tokyo, Japan

TEL

+81358380730

Homepage URL

Email

juken1123@hotmail.co.jp

Institute

Nishiarai Heart Center Hospital

Institute

Department

Personal name

Organization

Nishiarai Heart Center Hospital

Organization

Division

Category of Funding Organization

Self funding

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

2014

Year

06

Month

06

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

Completed

Date of protocol fixation

2013

Year

08

Month

01

Day

Date of IRB

Anticipated trial start date

2013

Year

10

Month

01

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2014

Year

06

Month

05

Day

Last modified on

2014

Year

06

Month

05

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016514