NCT03759067

Brief Summary

The study included 511 patients who underwent PCI because of angina during 2010-2011 at three Korean hospitals. Clopidogrel-naïve patients received either a loading dose (LD; 600 mg at 2-24 h before the procedure) or routine maintenance therapy (75 mg/day for ≥5 days) plus either a 300-mg reload (RL) or only the maintenance dose (MD).

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
511

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2010

Typical duration for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 18, 2010

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2012

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2013

Completed
5.3 years until next milestone

First Submitted

Initial submission to the registry

November 28, 2018

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 29, 2018

Completed
Last Updated

November 29, 2018

Status Verified

November 1, 2018

Enrollment Period

1.3 years

First QC Date

November 28, 2018

Last Update Submit

November 28, 2018

Conditions

Angina, Stable

Keywords

clopidogrel loadingmaintenance doseperiprocedural MI

Outcome Measures

Primary Outcomes (2)

  • 8hour mean CK-MB

    mean CK-MB(creatinine kinase myocardial band) is checked 8hour after PCI

    8hour after PCI

  • 24hour mean CK-MB

    mean CK-MB(creatinine kinase myocardial band) is checked 8hour after PCI

    24hour after PCI

Secondary Outcomes (4)

  • 8hour mean troponin-I

    8hour after PCI

  • Prevalence of periprocedural myocardial infarction (PMI)

    8hour or 24hour after PCI

  • All cause death

    9 months after PCI

  • Coronary revascularization

    9 months after PCI

Other Outcomes (1)

  • Moderate to severe GUSTO bleeding

    within 1week after PCI

Study Arms (3)

LD group

ACTIVE COMPARATOR

clopidogrel 600 mg once loading, usually 2-24 h before the procedure

Drug: clopidogrel 600mg

MD group

EXPERIMENTAL

After randomization, the routine therapy using daily clopidogrel 75mg

Drug: clopidogrel 75mg

RL group

ACTIVE COMPARATOR

After randomization, additional clopidogrel 300 mg reloading for patients who were taking a maintenance dose.

Drug: clopidogrel 75mgDrug: Clopidogrel 300 mg

Interventions

clopidogrel 75mgDRUG

clopidogrel once daily 75mg

Also known as: MD
MD groupRL group
Clopidogrel 300 mgDRUG

clopidogrel 300mg reloading

Also known as: RL
RL group
clopidogrel 600mgDRUG

clopidogrel 600mg loading

Also known as: LD
LD group

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Written informed consent and, stable angina pectoris and, at least 1 ischemic evidence below
  • Treadmil test positive
  • ST-T change in resting ECG or 24-hour ECG
  • Regional wall motion abnormality in Echocardiography or cardiac MRI
  • Myocardial ischemia at MIBI scan
  • moderate to severe stenosis at coronary CT angiography
  • chest pain or dyspnea

You may not qualify if:

  • AST or ALT \> 3 times upper normal limits
  • Serum creatinine \> 2.0 mg/dL
  • chronic malaborption status (disorder or operation)
  • planned surgery within 1 year
  • pregnancy or breast-feeding patients
  • life expectancy \< 1 year

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Mehran R, Rao SV, Bhatt DL, Gibson CM, Caixeta A, Eikelboom J, Kaul S, Wiviott SD, Menon V, Nikolsky E, Serebruany V, Valgimigli M, Vranckx P, Taggart D, Sabik JF, Cutlip DE, Krucoff MW, Ohman EM, Steg PG, White H. Standardized bleeding definitions for cardiovascular clinical trials: a consensus report from the Bleeding Academic Research Consortium. Circulation. 2011 Jun 14;123(23):2736-47. doi: 10.1161/CIRCULATIONAHA.110.009449. No abstract available.

    PMID: 21670242BACKGROUND

MeSH Terms

Conditions

Angina, Stable

Interventions

Clopidogrel

Condition Hierarchy (Ancestors)

Angina PectorisMyocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesChest PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

TiclopidineThienopyridinesThiophenesSulfur CompoundsOrganic ChemicalsPyridinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

November 28, 2018

First Posted

November 29, 2018

Study Start

October 18, 2010

Primary Completion

January 31, 2012

Study Completion

July 31, 2013

Last Updated

November 29, 2018

Record last verified: 2018-11

Data Sharing

IPD Sharing
Will not share