Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Registry of Acute Coronary Syndrome From University Hospital of Vigo (CardioCHUVI)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03664388
Recruitment Status : Recruiting
First Posted : September 10, 2018
Last Update Posted : September 10, 2018
Sponsor:
Information provided by (Responsible Party):
Hospital Álvaro Cunqueiro

Brief Summary:
CardoCHUVI registry was aim to study ischemic and bleeding complication after an acute coronary syndrome (ACS), both in-hospital and follow-up events.

Condition or disease Intervention/treatment
Acute Coronary Syndrome Drug: Dual antiplatelet therapy with ticagrelor/prasuglre

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


Layout table for study information
Study Type : Observational
Estimated Enrollment : 8000 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Registry of Patients Admitted by Acute Coronary Syndrome to University Hospital of Vigo
Actual Study Start Date : February 1, 2016
Actual Primary Completion Date : September 6, 2018
Estimated Study Completion Date : February 1, 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Ticagrelor


Intervention Details:
  • Drug: Dual antiplatelet therapy with ticagrelor/prasuglre
    Compare bleeding and ischemic events according to the type and duration of dual antiplatelet therapy
    Other Name: Dual antiplatelet therapy with clopidogrel


Primary Outcome Measures :
  1. All cause mortality [ Time Frame: Through study completion, an average of 3 years ]
    Death for any cause


Secondary Outcome Measures :
  1. Reinfarction [ Time Frame: Through study completion, an average of 3 years ]
    New spontaneous acute myocardial infarction

  2. Bleeding [ Time Frame: Through study completion, an average of 3 years ]
    Any bleeding according to BARC definition (from 1 to 5)

  3. Ischemic stroke [ Time Frame: Through study completion, an average of 3 years ]
    Ischemic stroke documented in CT

  4. Cancer [ Time Frame: Through study completion, an average of 3 years ]
    Any type of malignant cancer

  5. Heart Failure [ Time Frame: Through study completion, an average of 3 years ]
    Heart Failure admissions

  6. Atrial Fibrillation [ Time Frame: Through study completion, an average of 3 years ]
    Atrial fibrillation documented in ECG



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Consecutive patients admitted by acute coronary syndrome in the University Hospital Alvaro Cunqueiro of Vigo between January 2010 to January 2018
Criteria

Inclusion Criteria:

  • Any patient admitted to University Hospital Alvaro Cunqueiro of Vigo for acute coronary syndrome.

Exclusion Criteria:

  • Secondary acute coronary syndromes during a hospital admission for another cause (i.e. acute myocardial infarction in the context of a sepsis)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03664388


Contacts
Layout table for location contacts
Contact: Sergio Raposeiras Roubín, MD, PhD 0034 620170387 raposeiras26@hotmail.com
Contact: Emad Abu Assi, MD, PhD eabuassi@gmail.com

Locations
Layout table for location information
Spain
Department of Cardiology, Hospital Álvaro Cunqueiro Recruiting
Vigo, Pontevedra, Spain, 36312
Contact: ANDRES IÑIGUEZ ROMO, MD, PhD       andres.iniguez.romo@sergas.es   
Sponsors and Collaborators
Hospital Álvaro Cunqueiro
Investigators
Layout table for investigator information
Study Chair: Emad Abu-Assi, MD, PhD University Hospital Álvaro Cunqueiro, Vigo, Spain
Principal Investigator: Sergio Raposeiras-Roubín, MD, PhD University Hospital Álvaro Cunqueiro, Vigo, Spain
Study Director: Andres Iñiguez-Romo, MD, PhD University Hospital Álvaro Cunqueiro, Vigo, Spain

Layout table for additonal information
Responsible Party: Hospital Álvaro Cunqueiro
ClinicalTrials.gov Identifier: NCT03664388     History of Changes
Other Study ID Numbers: Hospital Alvaro Cunqueiro
First Posted: September 10, 2018    Key Record Dates
Last Update Posted: September 10, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: 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

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Hospital Álvaro Cunqueiro:
Acute Coronary Syndrome; Bleeding; Dual antiplatelet therapy

Additional relevant MeSH terms:
Layout table for MeSH terms
Acute Coronary Syndrome
Syndrome
Disease
Pathologic Processes
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Ticagrelor
Platelet Aggregation Inhibitors
Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs