Aspirin HypersensitivityADAPTEDNCT02848339
Aspirin Desensitization Registry in Patients With Aspirin Hypersensitivity
An observational study of Aspirin Hypersensitivity, run by Italian Society of Cardiology.
Trial summary
Data about aspirin desensitization for patients with coronary artery disease undergoing percutaneous coronary intervention are sparse. This is a prospective, multicenter, observational study including 7 italian centers, to assess safety and feasibility of a standard desensitization protocol in patients with aspirin… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aspirin Hypersensitivity
- What is being tested?
- aspirin
- How many people
- 330 participants
- Where
- No sites listed yet
- Study dates
- May 2010to Feb 2015
- How long will I take part?
- 12 Months
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with a history of aspirin hypersensitivity presenting with either an acute coronary syndrome or known/suspected stable coronary artery disease scheduled for coronary angiography with intent to undergo PCI
Who may be able to join
- history of aspirin hypersensitivity
- acute coronary syndrome or known/suspected stable coronary artery disease
- intent to undergo percutaneous coronary intervention
Who cannot join
- withdrawal of consent
About this study
Official title: Aspirin DesensitizAtion in PatienTs With Coronary artEry Disease: Results of a Multi Center Registry: the ADAPTED Registry
Data about aspirin desensitization for patients with coronary artery disease undergoing percutaneous coronary intervention are sparse.
This is a prospective, multicenter, observational study including 7 italian centers, to assess safety and feasibility of a standard desensitization protocol in patients with aspirin sensitivity undergoing coronary angiography. Patients with history of aspirin sensitivity undergoing coronary angiography are prospectively enrolled.All patients underwent the desensitization procedure with six sequential doses of aspirin (1, 5, 10, 20, 40, and 100 mg) administered orally at predefined intervals, with the procedure lasting 5.5 hours.All patients are followed for desensitization procedure success, description of reactions due to the desensitization procedure, and in hospital major adverse cardiac events (MACE). All patients are also followed-up for 12 months in order to assess their long-term risk of MACE, compliance with ASA therapy, and late occurrence of side reactions due to ASA sensitivity.
- Conditions
- Aspirin Hypersensitivity
- Being tested
- aspirin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
aspirinDrug
aspirin desensitization
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of patients with successful desensitization procedure
All patients are followed for desensitization procedure success, description of reactions due to the desensitization procedure.
Measured: 12 months
Major adverse cardiac events
Percentage of patients with an adverse cardiac event (cardiac death, myocardial infarction, stent thrombosis, stroke, destabilizing symptoms leading to hospitalization
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 Jul 2016 (estimated)
- Study startMay 2010
- Primary completionFeb 2015
- Study completionFeb 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Aspirin HypersensitivityStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 330 participants (actual)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Italian Society of Cardiology
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Roberta Rossini, Italian Society of Cardiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02848339
- Sponsor's protocol ID
- GISE
- Acronym
- ADAPTED
- Status last verified
- Jul 2016
- First submitted
- 22 Jul 2016
- Last updated
- 28 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes
Publications
Rossini R, Iorio A, Pozzi R, Bianco M, Musumeci G, Leonardi S, Lettieri C, Bossi I, Colombo P, Rigattieri S, Dossena C, Anzuini A, Capodanno D, Senni M, Angiolillo DJ. Aspirin Desensitization in Patients With Coronary Artery Disease: Results of the Multicenter ADAPTED Registry (Aspirin Desensitization in Patients With Coronary Artery Disease). Circ Cardiovasc Interv. 2017 Feb;10(2):e004368. doi: 10.1161/CIRCINTERVENTIONS.116.004368.
PubMed 28193678
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Aspirin DesensitizAtion in PatienTs With Coronary artEry Disease: Results of a Multi Center Registry: the ADAPTED Registry
- ClinicalTrials.gov ID
- NCT02848339
- Acronym / sponsor ID
- ADAPTED / GISE
- Conditions
- Aspirin Hypersensitivity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 330 participants (actual)
- Lead sponsor
- Italian Society of CardiologyUniversity, hospital or other
- Study start
- May 2010
- Primary completion
- Feb 2015 (actual)
- Study completion
- Feb 2015 (actual)
- First posted
- 28 Jul 2016 (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.
Data about aspirin desensitization for patients with coronary artery disease undergoing percutaneous coronary intervention are sparse.
This is a prospective, multicenter, observational study including 7 italian centers, to assess safety and feasibility of a standard desensitization protocol in patients with aspirin sensitivity undergoing coronary angiography. Patients with history of aspirin sensitivity undergoing coronary angiography are prospectively enrolled.All patients underwent the desensitization procedure with six sequential doses of aspirin (1, 5, 10, 20, 40, and 100 mg) administered orally at predefined intervals, with the procedure lasting 5.5 hours.All patients are followed for desensitization procedure success, description of reactions due to the desensitization procedure, and in hospital major adverse cardiac events (MACE). All patients are also followed-up for 12 months in order to assess their long-term risk of MACE, compliance with ASA therapy, and late occurrence of side reactions due to ASA sensitivity.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with a history of aspirin hypersensitivity presenting with either an acute coronary syndrome or known/suspected stable coronary artery disease scheduled for coronary angiography with intent to undergo PCI
Key inclusion criteria (3 listed)
- history of aspirin hypersensitivity
- acute coronary syndrome or known/suspected stable coronary artery disease
- intent to undergo percutaneous coronary intervention
Key exclusion criteria (1 listed)
- withdrawal of consent
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 |
|---|---|---|
| aspirinaspirin desensitization | Drug | – |
Primary outcome
Percentage of patients with successful desensitization procedure
Time frame: 12 months
All patients are followed for desensitization procedure success, description of reactions due to the desensitization procedure.
Major adverse cardiac events
Time frame: 12 months
Percentage of patients with an adverse cardiac event (cardiac death, myocardial infarction, stent thrombosis, stroke, destabilizing symptoms leading to hospitalization
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 28 Jul 2016.
- Derived from this study: PubMed 28193678Rossini R, Iorio A, Pozzi R, Bianco M, Musumeci G, Leonardi S, Lettieri C, Bossi I, Colombo P, Rigattieri S, Dossena C, Anzuini A, Capodanno D, Senni M, Angiolillo DJ. Aspirin Desensitization in Patients With Coronary Artery Disease: Results of the Multicenter ADAPTED Registry (Aspirin Desensitization in Patients With Coronary Artery Disease). Circ Cardiovasc Interv. 2017 Feb;10(2):e004368. doi: 10.1161/CIRCINTERVENTIONS.116.004368.
- Individual participant dataSharing planned: Yes
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Aspirin Hypersensitivity, run by Italian Society of Cardiology.
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 3 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: finished, as of the sponsor's last update on 28 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
Percentage of patients with successful desensitization procedure (time frame: 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02848339, which also lists 1 linked publication.
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 Jul 2016.