NCT02331511

Brief Summary

The purpose of this study is to determine whether Aspirin or Clopidogrel are effective in the prevention of venous obstruction after implantation of cardiac pacemaker or defibrillator.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2015

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

January 3, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 6, 2015

Completed
9 months until next milestone

Study Start

First participant enrolled

October 1, 2015

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2016

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
Last Updated

October 29, 2015

Status Verified

October 1, 2015

Enrollment Period

7 months

First QC Date

January 3, 2015

Last Update Submit

October 28, 2015

Conditions

Complication of Cardiac DefibrillatorDisorder of Cardiac Pacemaker SystemVenous Occlusion

Outcome Measures

Primary Outcomes (1)

  • Venus obstruction(axillary or subclavian vein) more than 50%(measure by venography)

    3 months

Secondary Outcomes (2)

  • major bleeding

    3 months

  • A composite of death of any cause, myocardial infarction, or cerebrovascular accident.

    3 months

Study Arms (3)

placebo

PLACEBO COMPARATOR

No antiplatelet drug

Drug: placebo

Aspirin

ACTIVE COMPARATOR

Aspirin 80 mg daily

Drug: Aspirin 80 mg daily

Clopidogrel

ACTIVE COMPARATOR

Clopidogrel 75mg daily

Drug: Clopidogrel 75 mg daily

Interventions

placeboDRUG

placebo administration for 3 months after device(PPM,ICD,CRT) implantation

Also known as: placebo 1 tablet daily
placebo
Aspirin 80 mg dailyDRUG

Aspirin 80 mg daily administration for 3 months after device(PPM,ICD,CRT) implantation

Also known as: Aspirin
Aspirin
Clopidogrel 75 mg dailyDRUG

Clopidogrel administration for 3 months after device(PPM,ICD,CRT) implantation

Also known as: Clopidogrel
Clopidogrel

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • patients who referred for first implantation of pacemaker, implantable cardiac defibrillator, or cardiac re synchronization therapy device

You may not qualify if:

  • history of malignancy
  • history of coagulopathy or platelet disorder
  • history of venous thromboembolism
  • history of gastrointestinal hemorrhage or active gastroduodenal ulcer in past 6 months
  • history of chronic kidney disorder or serum creatinine more than 1.5 mg/dl
  • patients who are on anticoagulant or other antithrombotic drugs or who must be on dual antiplatelet therapy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shahid ModaressHospital

Tehran, Tehran Province, Iran

RECRUITING

MeSH Terms

Interventions

AspirinClopidogrel

Intervention Hierarchy (Ancestors)

SalicylatesHydroxybenzoatesPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsTiclopidineThienopyridinesThiophenesSulfur CompoundsPyridinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • Morteza Saafi, M.D.

    Shahid Beheshti University of Medical Sciences

    STUDY CHAIR

  • Mohammad Ali Akbarzadeh, M.D.

    Shahid Beheshti University of Medical Sciences

    STUDY DIRECTOR

Central Study Contacts

Mohammad Ali Akbarzadeh, M.D.

CONTACT

+98 917 317 1001akbarzadehali@yahoo.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant proffesor of shahid beheshti university of medical sciences

Study Record Dates

First Submitted

January 3, 2015

First Posted

January 6, 2015

Study Start

October 1, 2015

Primary Completion

May 1, 2016

Study Completion

June 1, 2016

Last Updated

October 29, 2015

Record last verified: 2015-10

Locations

IR(1)