NCT00966485

Brief Summary

The investigators prospectively studied the effect of aspirin on platelet function in 106 stable outpatients 6 months after successful percutaneous coronary angioplasty. Participants were randomized in a double-blind, double-crossover study (80 or 500 mg per day for 6 months).T

Trial Health

87
On Track

Trial Health Score

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

Enrollment
106

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2006

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

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 1, 2006

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2008

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

August 24, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 27, 2009

Completed
Last Updated

August 27, 2009

Status Verified

August 1, 2009

Enrollment Period

2 years

First QC Date

August 24, 2009

Last Update Submit

August 25, 2009

Conditions

Coronary Stenting

Keywords

ASA resistancecoronary stentingplatelet functionlaboratory ASA resistanceMACEPositive SPECT

Outcome Measures

Primary Outcomes (1)

  • laboratory ASA resistance

    6 months

Secondary Outcomes (1)

  • major adverse cardiac events and positive cardiac scan for ischemia

    6 months

Study Arms (2)

80 mg ASA dose

ACTIVE COMPARATOR

6 months post stent on 80 mg ASA

Drug: 80 mg ASA dosing

500 mg ASA dose

ACTIVE COMPARATOR

6 months posr stent on ASA alone

Drug: 500 mg ASA dosing

Interventions

80 mg ASA dosingDRUG
80 mg ASA dose
500 mg ASA dosingDRUG
500 mg ASA dose

Eligibility Criteria

Age40 Years - 67 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • months post stent without complication

You may not qualify if:

  • subacute stent thrombosis
  • unable to discontinue plavix
  • dont accept to participate
  • contraindication for ASA use

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Namazi hospital

Shiraz, Fars, 55318, Iran

Location

Study Officials

  • javad kojuri, M.D.

    Shiraz University of Medical Sciences

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 24, 2009

First Posted

August 27, 2009

Study Start

October 1, 2006

Primary Completion

October 1, 2008

Study Completion

October 1, 2008

Last Updated

August 27, 2009

Record last verified: 2009-08

Locations

IR(1)