Coronary StentingNCT00966485
Dose-related Effect of Aspirin on Laboratory-defined Acetylsalicylic Acid Resistance and Clinical Outcome After Coronary Stenting
A study testing 80 mg ASA dosing and 500 mg ASA dosing in people with Coronary Stenting, run by Shiraz University of Medical Sciences at 1 site in Iran.
Trial 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 Read more about this study
- Who is it for?
- Ages 40 to 67 years
- Conditions the study is for
- Coronary Stenting
- What is being tested?
- 80 mg ASA dosing and 500 mg ASA dosing
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 106 participants
- Where
- 1 siteIran
- Study dates
- Oct 2006to Oct 2008
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 67 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 6 months post stent without complication
Who cannot join
- subacute stent thrombosis
- unable to discontinue plavix
- dont accept to participate
- contraindication for ASA use
Trial locations and contacts
1 site in 1 country.
About this study
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
Read the detailed description
Background:
Acetylsalicylic acid (aspirin) is widely used in the secondary prevention of coronary artery disease. There is controversy regarding the prevalence of aspirin resistance in patients with coronary artery disease and the effect of dose on resistance. Our primary aims were to determine the degree of platelet responsiveness to aspirin, and to study the influence of dose on platelet inhibition and clinical outcomes after coronary stenting.
- Conditions
- Coronary Stenting
- Being tested
- 80 mg ASA dosing, 500 mg ASA dosing
- Keywords
- ASA resistance, coronary stenting, platelet function, laboratory ASA resistance, MACE, Positive SPECT
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
80 mg ASA dosingDrug
500 mg ASA dosingDrug
| Study group | Role | What they receive |
|---|---|---|
| 80 mg ASA dose | Active comparator | 6 months post stent on 80 mg ASA Receives: Drug: 80 mg ASA dosing |
| 500 mg ASA dose | Active comparator | 6 months posr stent on ASA alone Receives: Drug: 500 mg ASA dosing |
What is being measured
The primary outcome is the main question the study is designed to answer.
laboratory ASA resistance
Measured: 6 months
Secondary outcomes (1)
major adverse cardiac events and positive cardiac scan for ischemia
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2009 (estimated)
- Study startOct 2006
- Primary completionOct 2008
- Study completionOct 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary StentingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 106 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shiraz University of Medical Sciences
- Sponsor type
- University, hospital or other
- Investigators
- javad kojuri, M.D., Study chair, Shiraz University of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00966485
- Sponsor's protocol ID
- 84-2230
- Status last verified
- Aug 2009
- First submitted
- 24 Aug 2009
- Last updated
- 27 Aug 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dose-related Effect of Aspirin on Laboratory-defined Acetylsalicylic Acid Resistance and Clinical Outcome After Coronary Stenting
- ClinicalTrials.gov ID
- NCT00966485
- Acronym / sponsor ID
- 84-2230
- Conditions
- Coronary Stenting
- Keywords
- ASA resistance, coronary stenting, platelet function, laboratory ASA resistance, MACE, Positive SPECT
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 106 participants (actual)
- Lead sponsor
- Shiraz University of Medical SciencesUniversity, hospital or other
- Study start
- Oct 2006
- Primary completion
- Oct 2008 (actual)
- Study completion
- Oct 2008 (actual)
- First posted
- 27 Aug 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
Background:
Acetylsalicylic acid (aspirin) is widely used in the secondary prevention of coronary artery disease. There is controversy regarding the prevalence of aspirin resistance in patients with coronary artery disease and the effect of dose on resistance. Our primary aims were to determine the degree of platelet responsiveness to aspirin, and to study the influence of dose on platelet inhibition and clinical outcomes after coronary stenting.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 80 mg ASA dose | Active comparator | Drug: 80 mg ASA dosing6 months post stent on 80 mg ASA |
| 500 mg ASA dose | Active comparator | Drug: 500 mg ASA dosing6 months posr stent on ASA alone |
Who may qualify
- Ages
- 40 to 67 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 6 months post stent without complication
Key exclusion criteria (4 listed)
- subacute stent thrombosis
- unable to discontinue plavix
- dont accept to participate
- contraindication for ASA use
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 80 mg ASA dosing | Drug | 80 mg ASA dose |
| 500 mg ASA dosing | Drug | 500 mg ASA dose |
Primary outcome
laboratory ASA resistance
Time frame: 6 months
1 secondary outcome
major adverse cardiac events and positive cardiac scan for ischemia
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2009.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
javad kojuri, M.D. study chair
Shiraz University of Medical Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 80 mg ASA dosing and 500 mg ASA dosing in people with Coronary Stenting, run by Shiraz University of Medical Sciences at 1 site in Iran.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Aug 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Iran. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
laboratory ASA resistance (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Aug 2009.