Acute Coronary SyndromeTOPICNCT02099422
Timing of Optimal Platelet Inhibition After Acute Coronary Syndrome
An observational study of Acute Coronary Syndrome and Coronary Stenting, run by Hôpital de la Timone at 1 site in France.
Trial summary
Comparison of two antiplatelet strategies between months 1 and 12 after coronary stenting for ACS. Efficiency and tolerance évaluation Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Acute Coronary Syndrome, Coronary Stenting, Antiplatelet Therapy
- How many people
- 500 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2013to Jan 2016
- Phase
- Observational
- 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 18 to 85 years
- All sexes
- Adult, Older adult
Study population: Patients with ACS treated by coronary stent implantation
Who may be able to join
- ACS and coronary stenting one month ago
Who cannot join
- age under 18 and pregnancy
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
CHU Timone hospital . Sc CARDIOLOGIE. Rue saint Pierre.
Marseille, 13005
thomas cuisset, MD-PHD, 33(0)491385981, thomas.cuisset@ap-hm.fr
thomas cuisset, MD-PHD
About this study
Official title: The Randomized TOPIC Study : Timing of Optimal Platelet Inhibition After Acute Coronary Syndrome
Comparison of two antiplatelet strategies between months 1 and 12 after coronary stenting for ACS. Efficiency and tolerance évaluation
- Medical subject headings
- Acute Coronary Syndrome
What is being measured
The primary outcome is the main question the study is designed to answer.
combined ischemic and hemorragic endpoint
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2014 (estimated)
- Study startJan 2013
- Primary completionJan 2015 (estimated)
- Study completionJan 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Coronary SyndromeStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hôpital de la Timone
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, CUISSET Thomas, Hôpital de la Timone
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02099422
- Sponsor's protocol ID
- APHM-011
- Other IDs
- 2013-A01168-37
- Acronym
- TOPIC
- Status last verified
- Mar 2014
- First submitted
- 26 Mar 2014
- Last updated
- 28 Mar 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Randomized TOPIC Study : Timing of Optimal Platelet Inhibition After Acute Coronary Syndrome
- ClinicalTrials.gov ID
- NCT02099422
- Acronym / sponsor ID
- TOPIC / APHM-011
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Hôpital de la TimoneUniversity, hospital or other
- Study start
- Jan 2013
- Primary completion
- Jan 2015 (estimated)
- Study completion
- Jan 2016 (estimated)
- First posted
- 28 Mar 2014 (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.
Comparison of two antiplatelet strategies between months 1 and 12 after coronary stenting for ACS. Efficiency and tolerance évaluation
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients with ACS treated by coronary stent implantation
Key inclusion criteria (1 listed)
- ACS and coronary stenting one month ago
Key exclusion criteria (1 listed)
- age under 18 and pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
combined ischemic and hemorragic endpoint
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2014.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Coronary Syndrome and Coronary Stenting, run by Hôpital de la Timone at 1 site in France.
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 1 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: status not confirmed, as of the sponsor's last update on 28 Mar 2014. 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 France. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact thomas cuisset, MD-PHD (33(0) 491385981, thomas.cuisset@ap-hm.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
combined ischemic and hemorragic endpoint (time frame: 12 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 28 Mar 2014.