Myocardial InfarctionPhase 4GRACIA3NCT00306228
Role of Tirofiban and the Paclitaxel Eluting Stent in Postfibrinolysis Angioplasty
A Phase 4 study testing Postfibrinolysis percutaneous coronary intervention in people with Myocardial Infarction, run by GRACIA Group at 1 site in Spain.
Trial summary
The conceptual hypothesis of this study is that, in patients with acute myocardial infarction and ST-segment elevation, the strategy of performing coronary angioplasty of the culprit artery with paclitaxel eluting stent significantly reduces the rate of restenosis in comparison with bare stents. 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?
- Postfibrinolysis percutaneous coronary intervention
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 436 participants
- Where
- 1 siteSpain
- Study dates
- Oct 2004to Jan 2009
- 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
- Patients with ST-segment elevation acute myocardial infarction with all of the following criteria will be eligible for enrollment:
- Age >18 years.
- Chest discomfort >30 minutes with no response to nitroglycerin.
- Time from the onset of symptoms to randomization < 12 hours.
- ST segment elevation > 1 mm in two or more limb leads or 2 mm in two or more contiguous precordial leads or non-diagnostic ECG (left bundle branch block or pacemaker rhythm) with classic symptoms.
- Killip class > 3.
- Written informed consent will be obtained.
Who cannot join
- Patients presenting with any of the following will not be included in the study.
- Cardiogenic shock defined as a systolic blood pressure <90 mm Hg without response to fluid administration or <100 mmHg in patients with supportive treatment and no bradycardia.
- Suspected mechanical complications of acute myocardial infarction.
- Previous CABG.
- Non-cardiac disease that is likely to jeopardize the planned termination of the study.
- Woman of childbearing potential unless a negative pregnant test.
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- Active bleeding and recent (within 2 weeks) surgery that contraindicate the use of heparin, tirofiban, or platelet aggregation inhibitors.
- Contraindications for thrombolytic use.
- previous hemorrhagic stroke at any time
- history of prior non-hemorrhagic cerebrovascular accident within 12 months
- intracerebral neoplasia
- active internal bleeding
- suspected aortic dissection
- Uncontrolled hypertension >180/110 in several measurements
- any other known intracerebral pathology not covered in contraindications
- Current use of anticoagulants or heparin use within 8 hours
- known bleeding diathesis
- recent trauma (< 4 weeks), including head trauma or traumatic or prolonged (>10 minutes) CPR or recent major surgery or biopsy (<8 weeks)
- noncompressible vascular punctures
- recent (< 4 weeks) internal bleeding
- pregnancy
- active peptic ulcer
- History of hypersensitivity to aspirin, ticlopidine, clopidogrel, heparin, tirofiban and stainless steel.
- Known renal failure, creatinine >2,5 mg/dL.
- Known impaired hepatic function that contraindicates the use of clopidogrel.
- Known thrombocytopenia (100.000).
- Participation in other trial.
- Known multivessel disease identified as no suitable for revascularization.
- Known peripheral vascular disease that difficult cardiac catheterization.
Trial locations and contacts
1 site in 1 country.
Spain1 site
Instituto de Ciencias del Corazón (ICICOR). Hospital Clínico Universitario de Valladolid
Valladolid, Valladolid, 47005
About this study
Official title: A Randomised Trial to Evaluate the Role of Paclitaxel Eluting Stent and Tirofiban to Improve the Results of Facilitated PCI in the Treatment of Acute ST- Segment Elevation Myocardial Infarction
The conceptual hypothesis of this study is that, in patients with acute myocardial infarction and ST-segment elevation, the strategy of performing coronary angioplasty of the culprit artery with paclitaxel eluting stent significantly reduces the rate of restenosis in comparison with bare stents.
The conceptual hypothesis of this study is that, in patients with acute myocardial infarction and ST-segment elevation, the strategy of performing coronary stent-angioplasty of the culprit artery under the protection of tirofiban 120 minutes after fibrinolytic significantly improves epicardial and myocardial infusion in comparison with the strategy of performing immediate intravenous thrombolysis (tenecteplase plus enoxaparine) followed by coronary angiography and adequate revascularization.
Read the detailed description
The primary objectives of this study are: first to determine the efficacy of paclitaxel eluting stent compared to conventional bare stent in terms of restenosis, and second to determine the effect of tirofiban administered prior to percutaneous coronary intervention (PCI) but 120 minutes after thrombolytic on the epicardial and myocardial flow after mechanical revascularization in patients with STEMI.
Methods: This is a phased 4, 2x2 randomised, open, multicenter, clinical study. Patients will be randomised 1:1:1:1 to four groups: a) paclitaxel eluting stent with tirofiban, b) paclitaxel eluting stent without tirofiban, c) bare stent with tirofiban and d) bare stent without tirofiban. A total of approximately 436 patients, with <12 hours STEMI will be enrolled. All patients will be initially treated with tenecteplase (TNK) and enoxaparin. Tirofiban will start 120 minutes after tenecteplase administration in those patients randomised to tirofiban. Cardiac catheterization will be performed within the first 3-12 hours after the study inclusion and stenting on the culprit artery, with the randomised paclitaxel or bare stent, will be performed.
The efficacy of these strategies will be measured in terms of: 1) binary restenosis, defined as >50% diameter stenosis and segment analysis including the stented segment as well as their margins, 5 mm proximal and distal to the stent at 9-12 months follow-up and, 2) the assessment of the epicardial and myocardial perfusion (%TIMI 3, CTFC, CFR-CTFC, TMP y DSA-TMP and the analysis of the normalization of the ST segment at 90 minutes, 3, 6, 12 and 24 hours after thrombolysis).
- Conditions
- Myocardial Infarction
- Being tested
- Postfibrinolysis percutaneous coronary intervention
- Keywords
- ST elevation acute myocardial infarction, Thrombolysis, Early routine percutaneous coronary intervention, tirofiban, paclitaxel
- Medical subject headings
- Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Postfibrinolysis percutaneous coronary interventionProcedure or surgery
Also called Express stents (Boston Scientific, Natick, Massachusetts)
implantation of a bare-metal stent with no infusion of tirofiban 120 minutes after fibrinolysis
Postfibrinolysis percutaneous coronary interventionProcedure or surgery
Also called Express stents (Boston Scientific, Natick, Massachusetts)
implantation of a bare-metal stent with infusion of tirofiban 120 minutes after fibrinolysis
Postfibrinolysis percutaneous coronary interventionProcedure or surgery
Also called TAXUS stents (Boston Scientific)
implantation of a paclitaxel eluting-stent with no infusion of tirofiban 120 minutes after fibrinolysis
Postfibrinolysis percutaneous coronary interventionProcedure or surgery
Also called TAXUS stents (Boston Scientific)
implantation of a paclitaxel eluting-stent with infusion of tirofiban 120 minutes after fibrinolysis
| Study group | Role | What they receive |
|---|---|---|
| bare-metal stent without tirofiban | Active comparator | implantation of a bare-metal stent with no tirofiban infusion after fibrinolysis Receives: Procedure: Postfibrinolysis percutaneous coronary intervention |
| bare-metal stent with tirofiban | Active comparator | implantation of a bare-metal stent with tirofiban infusion after fibrinolysis Receives: Procedure: Postfibrinolysis percutaneous coronary intervention |
| paclitaxel-eluting stent without tirofiban | Active comparator | implantation of a paclitaxel eluting-stent with no tirofiban after fibrinolysis Receives: Procedure: Postfibrinolysis percutaneous coronary intervention |
| paclitaxel-eluting stent with tirofiban | Active comparator | implantation of a paclitaxel eluting-stent with tirofiban infusion after fibrinolysis Receives: Procedure: Postfibrinolysis percutaneous coronary intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
to determine the efficacy of paclitaxel eluting stent compared to conventional bare stent in terms of restenosis
Measured: 12 months
to determine the effect of tirofiban administered prior to PCI but 120 minutes after thrombolytic on the epicardial and myocardial flow after mechanical revascularization in patients with STEMI
Measured: 24 hours
Secondary outcomes (6)
to determine the safety of paclitaxel eluting stent in terms of rate of complications, and particularly acute and subacute total occlusion.
Measured: 12 months
to determine the interaction of paclitaxel eluting stent and the complicated myocardial infarction lesion in terms of reduction of intimal proliferation as evaluated by quantitative coronary angiography
Measured: 12 months
to determine the efficacy of paclitaxel eluting stent in different subgroups of patients: diabetics, small vessel (<2.5 mm), long lesion (>15 mm), gender, and tirofiban use.
Measured: 12 months
to determine the efficacy and safety of full dose fibrinolytic therapy plus delayed tirofiban compared to fibrinolytic therapy alone in different subgroups: diabetics and the elderly
Measured: 30 days
to determine the efficacy of use of tirofiban in relation to time to fibrinolytic therapy and time to mechanical revascularization.
Measured: 24 hours
to determine possible interactions between the paclitaxel eluting stent and tirofiban in terms of restenosis or acute and subacute total occlusion following coronary stenting.
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 posted23 Mar 2006 (estimated)
- Study startOct 2004
- Primary completionJan 2008
- Study completionJan 2009
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 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
- 436 participants (actual)
Sponsor and investigators
- Lead sponsor
- GRACIA Group
- Sponsor type
- University, hospital or other
- Collaborators
- Spanish Ministry of Health., Ministry of Science and Innovation, Spain
- Investigators
- Francisco Fernandez-Aviles, MD, PhD, Study chair, ICICOR, Hospital Clínico Universitario Valladolid, Spain
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00306228
- Sponsor's protocol ID
- GRACIA 3
- Acronym
- GRACIA3
- Status last verified
- Sep 2009
- First submitted
- 21 Mar 2006
- Last updated
- 28 Sep 2009
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Sanchez 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 28 Sep 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised Trial to Evaluate the Role of Paclitaxel Eluting Stent and Tirofiban to Improve the Results of Facilitated PCI in the Treatment of Acute ST- Segment Elevation Myocardial Infarction
- ClinicalTrials.gov ID
- NCT00306228
- Acronym / sponsor ID
- GRACIA3 / GRACIA 3
- Conditions
- Myocardial Infarction
- Keywords
- ST elevation acute myocardial infarction, Thrombolysis, Early routine percutaneous coronary intervention, tirofiban, paclitaxel
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 436 participants (actual)
- Lead sponsor
- GRACIA GroupUniversity, hospital or other
- Collaborators
- Spanish Ministry of Health., Ministry of Science and Innovation, Spain
- Study start
- Oct 2004
- Primary completion
- Jan 2008 (actual)
- Study completion
- Jan 2009 (actual)
- First posted
- 23 Mar 2006 (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, in patients with acute myocardial infarction and ST-segment elevation, the strategy of performing coronary angioplasty of the culprit artery with paclitaxel eluting stent significantly reduces the rate of restenosis in comparison with bare stents.
The conceptual hypothesis of this study is that, in patients with acute myocardial infarction and ST-segment elevation, the strategy of performing coronary stent-angioplasty of the culprit artery under the protection of tirofiban 120 minutes after fibrinolytic significantly improves epicardial and myocardial infusion in comparison with the strategy of performing immediate intravenous thrombolysis (tenecteplase plus enoxaparine) followed by coronary angiography and adequate revascularization.
Detailed description
The primary objectives of this study are: first to determine the efficacy of paclitaxel eluting stent compared to conventional bare stent in terms of restenosis, and second to determine the effect of tirofiban administered prior to percutaneous coronary intervention (PCI) but 120 minutes after thrombolytic on the epicardial and myocardial flow after mechanical revascularization in patients with STEMI.
Methods: This is a phased 4, 2x2 randomised, open, multicenter, clinical study. Patients will be randomised 1:1:1:1 to four groups: a) paclitaxel eluting stent with tirofiban, b) paclitaxel eluting stent without tirofiban, c) bare stent with tirofiban and d) bare stent without tirofiban. A total of approximately 436 patients, with <12 hours STEMI will be enrolled. All patients will be initially treated with tenecteplase (TNK) and enoxaparin. Tirofiban will start 120 minutes after tenecteplase administration in those patients randomised to tirofiban. Cardiac catheterization will be performed within the first 3-12 hours after the study inclusion and stenting on the culprit artery, with the randomised paclitaxel or bare stent, will be performed.
The efficacy of these strategies will be measured in terms of: 1) binary restenosis, defined as >50% diameter stenosis and segment analysis including the stented segment as well as their margins, 5 mm proximal and distal to the stent at 9-12 months follow-up and, 2) the assessment of the epicardial and myocardial perfusion (%TIMI 3, CTFC, CFR-CTFC, TMP y DSA-TMP and the analysis of the normalization of the ST segment at 90 minutes, 3, 6, 12 and 24 hours after thrombolysis).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| bare-metal stent without tirofiban | Active comparator | Procedure: Postfibrinolysis percutaneous coronary interventionimplantation of a bare-metal stent with no tirofiban infusion after fibrinolysis |
| bare-metal stent with tirofiban | Active comparator | Procedure: Postfibrinolysis percutaneous coronary interventionimplantation of a bare-metal stent with tirofiban infusion after fibrinolysis |
| paclitaxel-eluting stent without tirofiban | Active comparator | Procedure: Postfibrinolysis percutaneous coronary interventionimplantation of a paclitaxel eluting-stent with no tirofiban after fibrinolysis |
| paclitaxel-eluting stent with tirofiban | Active comparator | Procedure: Postfibrinolysis percutaneous coronary interventionimplantation of a paclitaxel eluting-stent with tirofiban infusion after fibrinolysis |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patients with ST-segment elevation acute myocardial infarction with all of the following criteria will be eligible for enrollment:
- Age >18 years.
- Chest discomfort >30 minutes with no response to nitroglycerin.
- Time from the onset of symptoms to randomization < 12 hours.
- ST segment elevation > 1 mm in two or more limb leads or 2 mm in two or more contiguous precordial leads or non-diagnostic ECG (left bundle branch block or pacemaker rhythm) with classic symptoms.
Key exclusion criteria (29 listed)
- Patients presenting with any of the following will not be included in the study.
- Cardiogenic shock defined as a systolic blood pressure <90 mm Hg without response to fluid administration or <100 mmHg in patients with supportive treatment and no bradycardia.
- Suspected mechanical complications of acute myocardial infarction.
- Previous CABG.
- Non-cardiac disease that is likely to jeopardize the planned termination of the study.
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 |
|---|---|---|
| Postfibrinolysis percutaneous coronary interventionAlso: Express stents (Boston Scientific, Natick, Massachusetts)implantation of a bare-metal stent with no infusion of tirofiban 120 minutes after fibrinolysis | Procedure or surgery | bare-metal stent without tirofiban |
| Postfibrinolysis percutaneous coronary interventionAlso: Express stents (Boston Scientific, Natick, Massachusetts)implantation of a bare-metal stent with infusion of tirofiban 120 minutes after fibrinolysis | Procedure or surgery | bare-metal stent with tirofiban |
| Postfibrinolysis percutaneous coronary interventionAlso: TAXUS stents (Boston Scientific)implantation of a paclitaxel eluting-stent with no infusion of tirofiban 120 minutes after fibrinolysis | Procedure or surgery | paclitaxel-eluting stent without tirofiban |
| Postfibrinolysis percutaneous coronary interventionAlso: TAXUS stents (Boston Scientific)implantation of a paclitaxel eluting-stent with infusion of tirofiban 120 minutes after fibrinolysis | Procedure or surgery | paclitaxel-eluting stent with tirofiban |
Primary outcome
to determine the efficacy of paclitaxel eluting stent compared to conventional bare stent in terms of restenosis
Time frame: 12 months
to determine the effect of tirofiban administered prior to PCI but 120 minutes after thrombolytic on the epicardial and myocardial flow after mechanical revascularization in patients with STEMI
Time frame: 24 hours
6 secondary outcomes
to determine the safety of paclitaxel eluting stent in terms of rate of complications, and particularly acute and subacute total occlusion.
Time frame: 12 months
to determine the interaction of paclitaxel eluting stent and the complicated myocardial infarction lesion in terms of reduction of intimal proliferation as evaluated by quantitative coronary angiography
Time frame: 12 months
to determine the efficacy of paclitaxel eluting stent in different subgroups of patients: diabetics, small vessel (<2.5 mm), long lesion (>15 mm), gender, and tirofiban use.
Time frame: 12 months
to determine the efficacy and safety of full dose fibrinolytic therapy plus delayed tirofiban compared to fibrinolytic therapy alone in different subgroups: diabetics and the elderly
Time frame: 30 days
to determine the efficacy of use of tirofiban in relation to time to fibrinolytic therapy and time to mechanical revascularization.
Time frame: 24 hours
to determine possible interactions between the paclitaxel eluting stent and tirofiban in terms of restenosis or acute and subacute total occlusion following coronary stenting.
Time frame: 12 months
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 Sep 2009.
- Derived from this study: 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.
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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.
Francisco Fernandez-Aviles, MD, PhD study chair
ICICOR, Hospital Clínico Universitario Valladolid, Spain
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Postfibrinolysis percutaneous coronary intervention in people with Myocardial Infarction, run by GRACIA Group 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 7 inclusion and 29 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 Sep 2009. 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.
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?
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?
to determine the efficacy of paclitaxel eluting stent compared to conventional bare stent in terms of restenosis (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 NCT00306228, 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 Sep 2009.