Acute Myocardial InfarctionPhase 4Load & GoNCT00882739
Safety and Efficacy of Three Different Loading Doses of Clopidogrel, in Patients With Acute Myocardial Infarction
A Phase 4 study testing Clopidogrel 300 mg, Clopidogrel 600 mg and Clopidogrel 900 mg in people with Acute Myocardial Infarction, run by Ospedale San Donato at 1 site in Italy.
Trial summary
The aim of this study is to determine both safety and effectiveness of three different loading dose regimens of clopidogrel in patients with acute myocardial infarction undergoing primary angioplasty. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Myocardial Infarction
- What is being tested?
- Clopidogrel 300 mg, Clopidogrel 600 mg and Clopidogrel 900 mg
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 168 participants
- Where
- 1 siteItaly
- Study dates
- Apr 2009to Jul 2011
- 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
- ST-elevation myocardial infarction:
- chest pain lasting more than 30 minutes
- not responsive to nitrates
- ST-segment elevation of more than 0.1 mV in two or more leads on the ECG, or new Left Bundle Branch Block
- With indication to primary PCI, presenting within 12 hour from symptoms onset
- Age > 18 years
- Planned PCI
- Informed Consent
Who cannot join
- bleeding diathesis
- allergy to study drugs
- pregnancy
- the performance of a rescue PCI after thrombolysis
- known existence of a disease resulting in a life expectancy of <6 months
- lack of informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Safety and Efficacy of Three Different Loading Doses of Clopidogrel, Administered at First Medical Contact in Patients With Acute Myocardial Infarction Undergoing Primary Angioplasty. The LOAD & GO Trial
The aim of this study is to determine both safety and effectiveness of three different loading dose regimens of clopidogrel in patients with acute myocardial infarction undergoing primary angioplasty.
Read the detailed description
This study will enroll STEMI patients, who were planned to undergo PCI, and will randomize them to three different clopidogrel loading dose regimens at first medical contact: no pre-treatment, 600 mg or 900 mg. Platelet activity after administration of clopidogrel will be evaluated by VerifyNow™ P2Y12 point-of-care system.
The study is powered to demonstrate significant differences in the primary end point (the rate of TIMI Myocardial Perfusion Grade=3).
- Conditions
- Acute Myocardial Infarction
- Being tested
- Clopidogrel 300 mg, Clopidogrel 600 mg, Clopidogrel 900 mg
- Keywords
- angiography, percutaneous coronary intervention, Platelet Aggregation Inhibitors, Platelet Function Tests
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clopidogrel 300 mgDrug
Also called Plavix-®
Patients will receive a 300 mg clopidogrel loading dose in the cath-lab setting
Clopidogrel 600 mgDrug
Also called Plavix-®
Patients will receive a 600 mg clopidogrel loading dose at first medical contact
Clopidogrel 900 mgDrug
Also called Plavix-®
Patients will receive a 900 mg clopidogrel loading dose at first medical contact
| Study group | Role | What they receive |
|---|---|---|
| no pre-treatment | Other | No pre-treatment at first medical contact - Patients will receive a 300 mg clopidogrel loading dose in the cath-lab setting Receives: Drug: Clopidogrel 300 mg |
| 600 mg loading dose | Experimental | 600 mg clopidogrel loading dose at first medical contact Receives: Drug: Clopidogrel 600 mg |
| 900 mg loading dose | Experimental | 900 mg clopidogrel loading dose at first medical contact Receives: Drug: Clopidogrel 900 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
TIMI Myocardial Perfusion Grade (TMPG)
Measured: post-PCI
Secondary outcomes (7)
TIMI flow
Measured: pre- and post-PCI
Corrected TIMI Frame Count (cTFC)
Measured: post-PCI
Major bleedings
Measured: 30 days
Major adverse cardiac events (MACEs)
Measured: 30 days
Platelet Reactive Units (PRU) as assessed by VerifyNow™ System
Measured: pre-PCI
TIMI 2-3 grade flow of the infarct-related artery
Measured: pre-PCI
no reflow phenomenon
Measured: post-PCI
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2009 (estimated)
- Study startApr 2009
- Primary completionJul 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 168 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ospedale San Donato
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Leonardo Bolognese, Ospedale San Donato
- Investigators
- Leonardo Bolognese, MD, FESC, Principal investigator, Ospedale San DonatoKenneth Ducci, MD, Principal investigator, Ospedale San Donato
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00882739
- Sponsor's protocol ID
- Arezzo002
- Other IDs
- EUDRACT 2009-010295-23
- Acronym
- Load & Go
- Status last verified
- Jan 2012
- First submitted
- 15 Apr 2009
- Last updated
- 26 Jan 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Three Different Loading Doses of Clopidogrel, Administered at First Medical Contact in Patients With Acute Myocardial Infarction Undergoing Primary Angioplasty. The LOAD & GO Trial
- ClinicalTrials.gov ID
- NCT00882739
- Acronym / sponsor ID
- Load & Go / Arezzo002
- Conditions
- Acute Myocardial Infarction
- Keywords
- angiography, percutaneous coronary intervention, Platelet Aggregation Inhibitors, Platelet Function Tests
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 168 participants (actual)
- Lead sponsor
- Ospedale San DonatoUniversity, hospital or other
- Study start
- Apr 2009
- Primary completion
- Jul 2011 (actual)
- First posted
- 16 Apr 2009 (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 aim of this study is to determine both safety and effectiveness of three different loading dose regimens of clopidogrel in patients with acute myocardial infarction undergoing primary angioplasty.
Detailed description
This study will enroll STEMI patients, who were planned to undergo PCI, and will randomize them to three different clopidogrel loading dose regimens at first medical contact: no pre-treatment, 600 mg or 900 mg. Platelet activity after administration of clopidogrel will be evaluated by VerifyNow™ P2Y12 point-of-care system.
The study is powered to demonstrate significant differences in the primary end point (the rate of TIMI Myocardial Perfusion Grade=3).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| no pre-treatment | Other | Drug: Clopidogrel 300 mgNo pre-treatment at first medical contact - Patients will receive a 300 mg clopidogrel loading dose in the cath-lab setting |
| 600 mg loading dose | Experimental | Drug: Clopidogrel 600 mg600 mg clopidogrel loading dose at first medical contact |
| 900 mg loading dose | Experimental | Drug: Clopidogrel 900 mg900 mg clopidogrel loading dose at first medical contact |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- ST-elevation myocardial infarction:
- With indication to primary PCI, presenting within 12 hour from symptoms onset
- Age > 18 years
- Planned PCI
- Informed Consent
Key exclusion criteria (6 listed)
- bleeding diathesis
- allergy to study drugs
- pregnancy
- the performance of a rescue PCI after thrombolysis
- known existence of a disease resulting in a life expectancy of <6 months
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 |
|---|---|---|
| Clopidogrel 300 mgAlso: Plavix-®Patients will receive a 300 mg clopidogrel loading dose in the cath-lab setting | Drug | no pre-treatment |
| Clopidogrel 600 mgAlso: Plavix-®Patients will receive a 600 mg clopidogrel loading dose at first medical contact | Drug | 600 mg loading dose |
| Clopidogrel 900 mgAlso: Plavix-®Patients will receive a 900 mg clopidogrel loading dose at first medical contact | Drug | 900 mg loading dose |
Primary outcome
TIMI Myocardial Perfusion Grade (TMPG)
Time frame: post-PCI
7 secondary outcomes
TIMI flow
Time frame: pre- and post-PCI
Corrected TIMI Frame Count (cTFC)
Time frame: post-PCI
Major bleedings
Time frame: 30 days
Major adverse cardiac events (MACEs)
Time frame: 30 days
Platelet Reactive Units (PRU) as assessed by VerifyNow™ System
Time frame: pre-PCI
TIMI 2-3 grade flow of the infarct-related artery
Time frame: pre-PCI
no reflow phenomenon
Time frame: post-PCI
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 26 Jan 2012.
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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.
Leonardo Bolognese, MD, FESC principal investigator
Ospedale San Donato
Kenneth Ducci, MD principal investigator
Ospedale San Donato
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 Clopidogrel 300 mg, Clopidogrel 600 mg and Clopidogrel 900 mg in people with Acute Myocardial Infarction, run by Ospedale San Donato at 1 site in Italy.
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 8 inclusion and 6 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 26 Jan 2012. 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 Italy. 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?
TIMI Myocardial Perfusion Grade (TMPG) (time frame: post-PCI). 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 26 Jan 2012.