Acute Coronary SyndromeCardioCHUVINCT03664388
Registry of Acute Coronary Syndrome From University Hospital of Vigo
An observational study of Acute Coronary Syndrome, run by Hospital Álvaro Cunqueiro at 1 site in Spain.
Trial summary
CardoCHUVI registry was aim to study ischemic and bleeding complication after an acute coronary syndrome (ACS), both in-hospital and follow-up events. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Acute Coronary Syndrome
- What is being tested?
- Dual antiplatelet therapy with ticagrelor/prasuglre
- How many people
- 8,000 participants
- Where
- 1 siteSpain
- Study dates
- 1 Feb 2016to 1 Feb 2020
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Consecutive patients admitted by acute coronary syndrome in the University Hospital Alvaro Cunqueiro of Vigo between January 2010 to January 2018
Who may be able to join
- Any patient admitted to University Hospital Alvaro Cunqueiro of Vigo for acute coronary syndrome.
Who cannot join
- Secondary acute coronary syndromes during a hospital admission for another cause (i.e. acute myocardial infarction in the context of a sepsis)
Trial locations and contacts
1 site in 1 country.
Emad Abu Assi, MD, PhD contact
Spain1 site, 1 recruiting
- Recruiting
Department of Cardiology, Hospital Álvaro Cunqueiro
Vigo, Pontevedra, 36312
ANDRES IÑIGUEZ ROMO, MD, PhD, andres.iniguez.romo@sergas.es
About this study
Official title: Registry of Patients Admitted by Acute Coronary Syndrome to University Hospital of Vigo
CardoCHUVI registry was aim to study ischemic and bleeding complication after an acute coronary syndrome (ACS), both in-hospital and follow-up events.
Read the detailed description
CardioCHUVI is a retrospective study aim to analyze all consecutively patients admitted by acute coronary syndrome to University Hospital Alvaro Cunqueiro of Vigo, between January 2010 to January 2018
The objective of the project was to study cardiac and bleeding complications, such as reinfarction, heart failure, atrial fibrillation, stroke, and bleeding events, together with all-cause and cardiac mortality
- Conditions
- Acute Coronary Syndrome
- Being tested
- Dual antiplatelet therapy with ticagrelor/prasuglre
- Keywords
- Acute Coronary Syndrome; Bleeding; Dual antiplatelet therapy
- Medical subject headings
- Acute Coronary Syndrome, Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dual antiplatelet therapy with ticagrelor/prasuglreDrug
Also called Dual antiplatelet therapy with clopidogrel
Compare bleeding and ischemic events according to the type and duration of dual antiplatelet therapy
What is being measured
The primary outcome is the main question the study is designed to answer.
All cause mortality
Death for any cause
Measured: Through study completion, an average of 3 years
Secondary outcomes (6)
Reinfarction
New spontaneous acute myocardial infarction
Measured: Through study completion, an average of 3 years
Bleeding
Any bleeding according to BARC definition (from 1 to 5)
Measured: Through study completion, an average of 3 years
Ischemic stroke
Ischemic stroke documented in CT
Measured: Through study completion, an average of 3 years
Cancer
Any type of malignant cancer
Measured: Through study completion, an average of 3 years
Heart Failure
Heart Failure admissions
Measured: Through study completion, an average of 3 years
Atrial Fibrillation
Atrial fibrillation documented in ECG
Measured: Through study completion, an average of 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2018
- Study start1 Feb 2016
- Primary completion6 Sep 2018
- Study completion1 Feb 2020 (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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 8,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Álvaro Cunqueiro
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Emad Abu-Assi, MD, PhD, Study chair, University Hospital Álvaro Cunqueiro, Vigo, SpainSergio Raposeiras-Roubín, MD, PhD, Principal investigator, University Hospital Álvaro Cunqueiro, Vigo, SpainAndres Iñiguez-Romo, MD, PhD, Study director, University Hospital Álvaro Cunqueiro, Vigo, Spain
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03664388
- Sponsor's protocol ID
- Hospital Alvaro Cunqueiro
- Acronym
- CardioCHUVI
- Status last verified
- Sep 2018
- First submitted
- 6 Sep 2018
- Last updated
- 10 Sep 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Registry of all consecutive patients admitted by acute coronary syndrome (ACS) to an university hospital in order to analyze bleeding and ischemic complications according to the type and duration of dual antiplatelet therapy
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Registry of Patients Admitted by Acute Coronary Syndrome to University Hospital of Vigo
- ClinicalTrials.gov ID
- NCT03664388
- Acronym / sponsor ID
- CardioCHUVI / Hospital Alvaro Cunqueiro
- Conditions
- Acute Coronary Syndrome
- Keywords
- Acute Coronary Syndrome; Bleeding; Dual antiplatelet therapy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 8,000 participants (estimated)
- Lead sponsor
- Hospital Álvaro CunqueiroUniversity, hospital or other
- Study start
- 1 Feb 2016 (actual)
- Primary completion
- 6 Sep 2018 (actual)
- Study completion
- 1 Feb 2020 (estimated)
- First posted
- 10 Sep 2018 (actual)
- 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.
CardoCHUVI registry was aim to study ischemic and bleeding complication after an acute coronary syndrome (ACS), both in-hospital and follow-up events.
Detailed description
CardioCHUVI is a retrospective study aim to analyze all consecutively patients admitted by acute coronary syndrome to University Hospital Alvaro Cunqueiro of Vigo, between January 2010 to January 2018
The objective of the project was to study cardiac and bleeding complications, such as reinfarction, heart failure, atrial fibrillation, stroke, and bleeding events, together with all-cause and cardiac mortality
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Consecutive patients admitted by acute coronary syndrome in the University Hospital Alvaro Cunqueiro of Vigo between January 2010 to January 2018
Key inclusion criteria (1 listed)
- Any patient admitted to University Hospital Alvaro Cunqueiro of Vigo for acute coronary syndrome.
Key exclusion criteria (1 listed)
- Secondary acute coronary syndromes during a hospital admission for another cause (i.e. acute myocardial infarction in the context of a sepsis)
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 |
|---|---|---|
| Dual antiplatelet therapy with ticagrelor/prasuglreAlso: Dual antiplatelet therapy with clopidogrelCompare bleeding and ischemic events according to the type and duration of dual antiplatelet therapy | Drug | – |
Primary outcome
All cause mortality
Time frame: Through study completion, an average of 3 years
Death for any cause
6 secondary outcomes
Reinfarction
Time frame: Through study completion, an average of 3 years
Bleeding
Time frame: Through study completion, an average of 3 years
Ischemic stroke
Time frame: Through study completion, an average of 3 years
Cancer
Time frame: Through study completion, an average of 3 years
Heart Failure
Time frame: Through study completion, an average of 3 years
Atrial Fibrillation
Time frame: Through study completion, an average of 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2018.
- Individual participant dataSharing planned: No. Registry of all consecutive patients admitted by acute coronary syndrome (ACS) to an university hospital in order to analyze bleeding and ischemic complications according to the type and duration of dual antiplatelet therapy
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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.
Emad Abu Assi, MD, PhD contact
Emad Abu-Assi, MD, PhD study chair
University Hospital Álvaro Cunqueiro, Vigo, Spain
Sergio Raposeiras-Roubín, MD, PhD principal investigator
University Hospital Álvaro Cunqueiro, Vigo, Spain
Andres Iñiguez-Romo, MD, PhD study director
University Hospital Álvaro Cunqueiro, Vigo, Spain
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, run by Hospital Álvaro Cunqueiro at 1 site in Spain.
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 10 Sep 2018. 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 Spain. 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 Sergio Raposeiras Roubín, MD, PhD (0034 620170387, raposeiras26@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
All cause mortality (time frame: Through study completion, an average of 3 years). 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 10 Sep 2018.