Myocardial InfarctionPhase 4GRACIA4NCT02268669
Comparison of Primary PCI vs. Post-thrombolysis PCI as Reperfusion Strategies in STEMI
A Phase 4 study testing Reperfusion strategies in people with Myocardial Infarction, run by GRACIA Group.
Trial summary
The conceptual hypothesis of this study is that primary angioplasty is superior to a combined strategy of immediate thrombolysis followed by routine angioplasty in patients with ST-segment elevation acute myocardial infarction (STEMI), even with the inherent delay of the transfer of these patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myocardial Infarction
- What is being tested?
- Reperfusion strategies
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,444 participants
- Where
- No sites listed yet
- Study dates
- May 2010to Mar 2016
- Phase
- Phase 4
- 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
Who may be able to join
- Age >18 years
- Chest discomfort > 30 minutes with no response to nitroglycerin
- Time from the onset of symptoms to randomization between 0 and 12 hours
- ST segment elevation > 1 mm in two or more contiguos precordial leads or non-diagnostic ECG (left bundle branch block or pacemarker rhythm) with classic symptoms.
- Killip class equal or less than 3
- Written informed consent
Who cannot join
- Cardiogenic shock defined as a systolic blood pressure <90 mm Hg without response to fluid administration or <100 mm Hg in patients with supportive treatment and no bradycardia
- Suspicion or evidence of mechanical complications of STEMI
- Non-cardiac disease that is likely to jeopardize compliance with follow-up schedule of the study (life expectancy < 1 year)
- woman of childbearing potential unless a negative pregnant test
- Major contraindications for thrombolytic therapy
- Participation in other trial
- Known multivessel disease identified as unsuitable for revascularization
- Known peripheral vascular disease that complicates cardiac catheterization
About this study
Official title: A Randomized Clinical Trial Comparing Primary PCI and Post-thrombolysis PCI as Reperfusion Strategies in Patients With ST Segment Elevation Acute Myocardial Infarction
The conceptual hypothesis of this study is that primary angioplasty is superior to a combined strategy of immediate thrombolysis followed by routine angioplasty in patients with ST-segment elevation acute myocardial infarction (STEMI), even with the inherent delay of the transfer of these patients.
Read the detailed description
This is a randomized, multicenter, open-label clinical trial comparing two strategies of reperfusion in STEMI. Patients will be randomly allocated to: primary angioplasty or post-thrombolysis angioplasty. A clinical follow-up will be performed at 12 months. In this trial, 1444 patients with STEMI will be randomized to primary angioplasty with immediate stent implantation in at least the infarct related artery (IRA) under bivalirudin protection, or to a combined strategy of immediate thrombolysis with tenecteplase (TNK) and enoxaparin followed by cardiac catheterization and adequate revascularization when indicated during the next morning after randomization.
Primary endpoint:
To compare the clinical efficacy (incidence of the composite endpoint formed by death, reinfarction, new revascularization, rehospitalization or severe hemorrhage within 12 months) of primary angioplasty versus thrombolytic treatment followed by percutaneous coronary intervention (PCI) the next day in patients with STEMI.
Secondary endpoints:
- Components of the composite endpoint individually analysed at 12 months (death, reinfarction, new revascularization, rehospitalization and severe hemorrhage).
- Cardiovascular mortality and its different components (pre-specified in the case report forms, CRF) at 12 months.
- Incidence of the composite endpoint formed by death, reinfarction, new revascularization, rehospitalization and/or hemorrhage at 30 days.
- Incidence of major bleeding events during hospitalization and at 30 days.
- To compare the clinical efficacy of both treatments according to the timing of presentation after symptom onset (0 to 3 hours, >3-6 hours, and >6-12 hours), to the patient´s age (> or < 75 years), to the infarction localization (anterior or inferior), to gender (male or female), to the presence of diabetes mellitus and to the characteristics of the recruiting center (with or without 24-hour catheterization facilities).
- Incidence of the composite endpoint formed by death, reinfarction, new revascularization, rehospitalization and/or hemorrhage at 3 years.
- Components of the composite endpoint individually analysed at 3 years (death, reinfarction, new revascularization, rehospitalization and severe hemorrhage).
- Analysis of stent thrombosis according to the Academic Research Consortium (ARC) definition (http://www.fda.gov/ohrms/dockets/ac/06/transcripts/2006-4253t2.rtf.) within 30 days, 12 months and 3 years.
- To compare the combination of death, reinfarction, revascularization, rehospitalization and/or major hemorrhage of patients treated with primary angioplasty versus those assigned to the postrombolysis angioplasty who underwent catheterization the following day within 30 days, 12 months and 3 years.
- To compare every indivicual components of the combine endpoint (death, reinfarction, revascularization, rehospitalization and major hemorrhage) of patients treated with primary angioplasty versus those assigned to the postrombolysis angioplasty who underwent catheterization the following day within 30 days, 12 months and 3 years.
- To compare the cost-effectiveness relationship (cost of maintaining a patient alive and without adverse cardiovascular events within the first year post-infarction) of both strategies.
- Conditions
- Myocardial Infarction
- Being tested
- Reperfusion strategies
- Keywords
- primary angioplasty, post-thrombolysis angioplasty, ST elevation acute myocardial infarction
- Medical subject headings
- Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Reperfusion strategiesOther
Two different reperfusion strategies in STEMI will be compared: primary angioplasty vs. post-thrombolysis angioplasty
| Study group | Role | What they receive |
|---|---|---|
| Primary angioplasty | Active comparator | Patients assigned to this treatment will undergo cardiac catheterization within the time recommended by current guidelines. Double antiagregation will be used, vascular access wil be obtained and bivalirudin will be used as anticoagulation; all following current guidelines recommendations Receives: Other: Reperfusion strategies |
| Post-thrombolysis angioplasty | Active comparator | Patients will receive tenecteplase, enoxaparin, and double antiagreagation with clopidogrel or aspirin as recommended guidelines. Criteria of no reperfusion after fibrinolysis is defined as absence of ST-segment lowering >50%, 90 minutes after fibrinolysis. If not reperfusion is achieved recue angiplasty will be performed inmmediately if reperfusion is achieved cardiac catheterization will be performed the mornig following the day of randomization Receives: Other: Reperfusion strategies |
What is being measured
The primary outcome is the main question the study is designed to answer.
incidence of the composite endpoint formed by death, reinfarction, new revascularization, rehospitalization or severe hemorrhage
To compare the clinical efficacy (incidence of the composite endpoint formed by death, reinfarction, new revascularization, rehospitalization or severe hemorrhage within 12 months) of primary angioplasty versus post-thrombolytic angioplasty
Measured: 12 months
Secondary outcomes (17)
Incidence of death
Components of the composite endpoint individually analysed at 12 months (death, reinfarction, new revascularization, rehospitalization and severe hemorrhage).
Measured: 12 months
Incidence of myocardial reinfaction
Components of the composite endpoint individually analysed at 12 months (death, reinfarction, new revascularization, rehospitalization and severe hemorrhage).
Measured: 12 months
Incidence of new revascularization
Components of the composite endpoint individually analysed at 12 months (death, reinfarction, new revascularization, rehospitalization and severe hemorrhage).
Measured: 12 months
Incidence of rehospitalization
Components of the composite endpoint individually analysed at 12 months (death, reinfarction, new revascularization, rehospitalization and severe hemorrhage).
Measured: 12 months
Incidence of cardiovascular mortality
Measured: 12 months
Incidence of the composite endpoint formed by death, reinfarction, new revascularization, rehospitalization and/or hemorrhage
Measured: 30 days
Incidence of major bleeding events
Measured: Hospitalization and at 30 days
clinical efficacy according to timing of presentation (<3, 3-6, and >6 hours), patient´s age (> or < 75 years), infarction localization, gender, presence of diabetes and recruiting center (with or without catheterization facilities)
Measured: 12 months
Incidence of the composite endpoint formed by death, reinfarction, new revascularization, rehospitalization and/or hemorrhage
Measured: 3 years
Incidence of death
Measured: 3 years
Incidence of reinfarction
Measured: 3 years
Incidence of new revascularization
Measured: 3 years
Incidence of rehospitalization
Measured: 3 years
Analysis of stent thrombosis according to the Academic Research Consortium (ARC) definition (http://www.fda.gov/ohrms/dockets/ac/06/transcripts/2006-4253t2.rtf.)
Measured: 30 days, 12 months and 3 years
Combination of death, reinfarction, revascularization, rehospitalization and/or major hemorrhage of patients treated with primary angioplasty vs. those assigned to postrombolysis angioplasty undergoing catheterization the following day
Measured: 30 days, 12 months and 3 years
To compare every indivicual components of the combine endpoint of patients treated with primary angioplasty versus those assigned to the postrombolysis angioplasty who underwent catheterization the following day
Measured: 30 days, 12 months and 3 years
To compare the cost-effectiveness relationship (cost of maintaining a patient alive and without adverse cardiovascular events within the first year post-infarction) of both strategies
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 posted20 Oct 2014 (estimated)
- Study startMay 2010
- Primary completionOct 2014
- Study completionMar 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Myocardial InfarctionStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 1,444 participants (actual)
Sponsor and investigators
- Lead sponsor
- GRACIA Group
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pedro L Sanchez, GRACIA Group
- Investigators
- Francisco Fernandez-Aviles, MD, PhD, Study chair, faviles@secardiologia.es
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02268669
- Sponsor's protocol ID
- GRACIA4
- Acronym
- GRACIA4
- Status last verified
- Oct 2014
- First submitted
- 13 Oct 2014
- Last updated
- 20 Oct 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Fernandez-Aviles F, Alonso JJ, Castro-Beiras A, Vazquez N, Blanco J, Alonso-Briales J, Lopez-Mesa J, Fernandez-Vazquez F, Calvo I, Martinez-Elbal L, San Roman JA, Ramos B; GRACIA (Grupo de Analisis de la Cardiopatia Isquemica Aguda) Group. Routine invasive strategy within 24 hours of thrombolysis versus ischaemia-guided conservative approach for acute myocardial infarction with ST-segment elevation (GRACIA-1): a randomised controlled trial. Lancet. 2004 Sep 18-24;364(9439):1045-53. doi: 10.1016/S0140-6736(04)17059-1.
PubMed 15380963Fernandez-Aviles F, Alonso JJ, Pena G, Blanco J, Alonso-Briales J, Lopez-Mesa J, Fernandez-Vazquez F, Moreu J, Hernandez RA, Castro-Beiras A, Gabriel R, Gibson CM, Sanchez PL; GRACIA-2 (Groupo de Analisis de Cardiopatia Isquemica Aguda) Investigators. Primary angioplasty vs. early routine post-fibrinolysis angioplasty for acute myocardial infarction with ST-segment elevation: the GRACIA-2 non-inferiority, randomized, controlled trial. Eur Heart J. 2007 Apr;28(8):949-60. doi: 10.1093/eurheartj/ehl461. Epub 2007 Jan 23.
PubMed 17244641Sanchez PL, Gimeno F, Ancillo P, Sanz JJ, Alonso-Briales JH, Bosa F, Santos I, Sanchis J, Bethencourt A, Lopez-Messa J, de Prado AP, Alonso JJ, San Roman JA, Fernandez-Aviles F. Role of the paclitaxel-eluting stent and tirofiban in patients with ST-elevation myocardial infarction undergoing postfibrinolysis angioplasty: the GRACIA-3 randomized clinical trial. Circ Cardiovasc Interv. 2010 Aug;3(4):297-307. doi: 10.1161/CIRCINTERVENTIONS.109.920868.
PubMed 20716757
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Clinical Trial Comparing Primary PCI and Post-thrombolysis PCI as Reperfusion Strategies in Patients With ST Segment Elevation Acute Myocardial Infarction
- ClinicalTrials.gov ID
- NCT02268669
- Acronym / sponsor ID
- GRACIA4 / GRACIA4
- Conditions
- Myocardial Infarction
- Keywords
- primary angioplasty, post-thrombolysis angioplasty, ST elevation acute myocardial infarction
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,444 participants (actual)
- Lead sponsor
- GRACIA GroupUniversity, hospital or other
- Study start
- May 2010
- Primary completion
- Oct 2014 (actual)
- Study completion
- Mar 2016 (estimated)
- First posted
- 20 Oct 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.
The conceptual hypothesis of this study is that primary angioplasty is superior to a combined strategy of immediate thrombolysis followed by routine angioplasty in patients with ST-segment elevation acute myocardial infarction (STEMI), even with the inherent delay of the transfer of these patients.
Detailed description
This is a randomized, multicenter, open-label clinical trial comparing two strategies of reperfusion in STEMI. Patients will be randomly allocated to: primary angioplasty or post-thrombolysis angioplasty. A clinical follow-up will be performed at 12 months. In this trial, 1444 patients with STEMI will be randomized to primary angioplasty with immediate stent implantation in at least the infarct related artery (IRA) under bivalirudin protection, or to a combined strategy of immediate thrombolysis with tenecteplase (TNK) and enoxaparin followed by cardiac catheterization and adequate revascularization when indicated during the next morning after randomization.
Primary endpoint:
To compare the clinical efficacy (incidence of the composite endpoint formed by death, reinfarction, new revascularization, rehospitalization or severe hemorrhage within 12 months) of primary angioplasty versus thrombolytic treatment followed by percutaneous coronary intervention (PCI) the next day in patients with STEMI.
Secondary endpoints:
- Components of the composite endpoint individually analysed at 12 months (death, reinfarction, new revascularization, rehospitalization and severe hemorrhage).
- Cardiovascular mortality and its different components (pre-specified in the case report forms, CRF) at 12 months.
- Incidence of the composite endpoint formed by death, reinfarction, new revascularization, rehospitalization and/or hemorrhage at 30 days.
- Incidence of major bleeding events during hospitalization and at 30 days.
- To compare the clinical efficacy of both treatments according to the timing of presentation after symptom onset (0 to 3 hours, >3-6 hours, and >6-12 hours), to the patient´s age (> or < 75 years), to the infarction localization (anterior or inferior), to gender (male or female), to the presence of diabetes mellitus and to the characteristics of the recruiting center (with or without 24-hour catheterization facilities).
- Incidence of the composite endpoint formed by death, reinfarction, new revascularization, rehospitalization and/or hemorrhage at 3 years.
- Components of the composite endpoint individually analysed at 3 years (death, reinfarction, new revascularization, rehospitalization and severe hemorrhage).
- Analysis of stent thrombosis according to the Academic Research Consortium (ARC) definition (http://www.fda.gov/ohrms/dockets/ac/06/transcripts/2006-4253t2.rtf.) within 30 days, 12 months and 3 years.
- To compare the combination of death, reinfarction, revascularization, rehospitalization and/or major hemorrhage of patients treated with primary angioplasty versus those assigned to the postrombolysis angioplasty who underwent catheterization the following day within 30 days, 12 months and 3 years.
- To compare every indivicual components of the combine endpoint (death, reinfarction, revascularization, rehospitalization and major hemorrhage) of patients treated with primary angioplasty versus those assigned to the postrombolysis angioplasty who underwent catheterization the following day within 30 days, 12 months and 3 years.
- To compare the cost-effectiveness relationship (cost of maintaining a patient alive and without adverse cardiovascular events within the first year post-infarction) of both strategies.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Primary angioplasty | Active comparator | Other: Reperfusion strategiesPatients assigned to this treatment will undergo cardiac catheterization within the time recommended by current guidelines. Double antiagregation will be used, vascular access wil be obtained and bivalirudin will be used as anticoagulation; all following current guidelines recommendations |
| Post-thrombolysis angioplasty | Active comparator | Other: Reperfusion strategiesPatients will receive tenecteplase, enoxaparin, and double antiagreagation with clopidogrel or aspirin as recommended guidelines. Criteria of no reperfusion after fibrinolysis is defined as absence of ST-segment lowering >50%, 90 minutes after fibrinolysis. If not reperfusion is achieved recue angiplasty will be performed inmmediately if reperfusion is achieved cardiac catheterization will be performed the mornig following the day of randomization |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age >18 years
- Chest discomfort > 30 minutes with no response to nitroglycerin
- Time from the onset of symptoms to randomization between 0 and 12 hours
- ST segment elevation > 1 mm in two or more contiguos precordial leads or non-diagnostic ECG (left bundle branch block or pacemarker rhythm) with classic symptoms.
- Killip class equal or less than 3
Key exclusion criteria (8 listed)
- Cardiogenic shock defined as a systolic blood pressure <90 mm Hg without response to fluid administration or <100 mm Hg in patients with supportive treatment and no bradycardia
- Suspicion or evidence of mechanical complications of STEMI
- Non-cardiac disease that is likely to jeopardize compliance with follow-up schedule of the study (life expectancy < 1 year)
- woman of childbearing potential unless a negative pregnant test
- Major contraindications for thrombolytic therapy
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 |
|---|---|---|
| Reperfusion strategiesTwo different reperfusion strategies in STEMI will be compared: primary angioplasty vs. post-thrombolysis angioplasty | Other | Post-thrombolysis angioplasty, Primary angioplasty |
Primary outcome
incidence of the composite endpoint formed by death, reinfarction, new revascularization, rehospitalization or severe hemorrhage
Time frame: 12 months
To compare the clinical efficacy (incidence of the composite endpoint formed by death, reinfarction, new revascularization, rehospitalization or severe hemorrhage within 12 months) of primary angioplasty versus post-thrombolytic angioplasty
17 secondary outcomes
Incidence of death
Time frame: 12 months
Incidence of myocardial reinfaction
Time frame: 12 months
Incidence of new revascularization
Time frame: 12 months
Incidence of rehospitalization
Time frame: 12 months
Incidence of cardiovascular mortality
Time frame: 12 months
Incidence of the composite endpoint formed by death, reinfarction, new revascularization, rehospitalization and/or hemorrhage
Time frame: 30 days
Incidence of major bleeding events
Time frame: Hospitalization and at 30 days
clinical efficacy according to timing of presentation (<3, 3-6, and >6 hours), patient´s age (> or < 75 years), infarction localization, gender, presence of diabetes and recruiting center (with or without catheterization facilities)
Time frame: 12 months
Incidence of the composite endpoint formed by death, reinfarction, new revascularization, rehospitalization and/or hemorrhage
Time frame: 3 years
Incidence of death
Time frame: 3 years
Incidence of reinfarction
Time frame: 3 years
Incidence of new revascularization
Time frame: 3 years
Incidence of rehospitalization
Time frame: 3 years
Analysis of stent thrombosis according to the Academic Research Consortium (ARC) definition (http://www.fda.gov/ohrms/dockets/ac/06/transcripts/2006-4253t2.rtf.)
Time frame: 30 days, 12 months and 3 years
Combination of death, reinfarction, revascularization, rehospitalization and/or major hemorrhage of patients treated with primary angioplasty vs. those assigned to postrombolysis angioplasty undergoing catheterization the following day
Time frame: 30 days, 12 months and 3 years
To compare every indivicual components of the combine endpoint of patients treated with primary angioplasty versus those assigned to the postrombolysis angioplasty who underwent catheterization the following day
Time frame: 30 days, 12 months and 3 years
To compare the cost-effectiveness relationship (cost of maintaining a patient alive and without adverse cardiovascular events within the first year post-infarction) of both strategies
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 20 Oct 2014.
- Background: PubMed 15380963Fernandez-Aviles F, Alonso JJ, Castro-Beiras A, Vazquez N, Blanco J, Alonso-Briales J, Lopez-Mesa J, Fernandez-Vazquez F, Calvo I, Martinez-Elbal L, San Roman JA, Ramos B; GRACIA (Grupo de Analisis de la Cardiopatia Isquemica Aguda) Group. Routine invasive strategy within 24 hours of thrombolysis versus ischaemia-guided conservative approach for acute myocardial infarction with ST-segment elevation (GRACIA-1): a randomised controlled trial. Lancet. 2004 Sep 18-24;364(9439):1045-53. doi: 10.1016/S0140-6736(04)17059-1.
- Background: PubMed 17244641Fernandez-Aviles F, Alonso JJ, Pena G, Blanco J, Alonso-Briales J, Lopez-Mesa J, Fernandez-Vazquez F, Moreu J, Hernandez RA, Castro-Beiras A, Gabriel R, Gibson CM, Sanchez PL; GRACIA-2 (Groupo de Analisis de Cardiopatia Isquemica Aguda) Investigators. Primary angioplasty vs. early routine post-fibrinolysis angioplasty for acute myocardial infarction with ST-segment elevation: the GRACIA-2 non-inferiority, randomized, controlled trial. Eur Heart J. 2007 Apr;28(8):949-60. doi: 10.1093/eurheartj/ehl461. Epub 2007 Jan 23.
- Background: PubMed 20716757Sanchez PL, Gimeno F, Ancillo P, Sanz JJ, Alonso-Briales JH, Bosa F, Santos I, Sanchis J, Bethencourt A, Lopez-Messa J, de Prado AP, Alonso JJ, San Roman JA, Fernandez-Aviles F. Role of the paclitaxel-eluting stent and tirofiban in patients with ST-elevation myocardial infarction undergoing postfibrinolysis angioplasty: the GRACIA-3 randomized clinical trial. Circ Cardiovasc Interv. 2010 Aug;3(4):297-307. doi: 10.1161/CIRCINTERVENTIONS.109.920868.
Related trials for Myocardial Infarction
Not yet recruitingPhase 4
Roxadustat and Myocardial Injury After Off-Pump Coronary Artery Bypass Surgery
Coronary Artery Disease, Coronary Artery Bypass Grafting
Active, not recruitingObservational study
A Longitudinal Cohort Study to Evaluate Cardiovascular Risk Factors and Disease in Haiti
Hypertension, Diabetes
Active, not recruitingPhase 3
A Study of Inclisiran to Prevent Cardiovascular Events in High-risk Primary Prevention Patients.
Primary Prevention of Atherosclerotic Cardiovascular Disease
Enrolling by invitation
The DANE-HEART Trial - Computed Tomography Coronary Angiography for Primary Prevention
Coronary Atherosclerosis and Other Heart Disease, Cardiovascular Diseases
Not yet recruitingObservational study
Elicit Drugs in Myocardial Infarction
Young Patients With Acute Myocardial Infarction
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.
Francisco Fernandez-Aviles, MD, PhD study chair
faviles@secardiologia.es
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Reperfusion strategies in people with Myocardial Infarction, run by GRACIA Group.
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 6 inclusion and 8 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 20 Oct 2014. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
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?
incidence of the composite endpoint formed by death, reinfarction, new revascularization, rehospitalization or severe hemorrhage (time frame: 12 months). 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 NCT02268669, which also lists 3 linked publications.
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 20 Oct 2014.