Acute Coronary SyndromePhase 4NCT01572129
Clopidogrel Reloading in Patients With NSTEACS Undergoing Percutaneous Coronary Intervention on Chronic Clopidogrel Therapy
A Phase 4 study testing Clopidogrel in people with Acute Coronary Syndrome and Myocardial Infarction, run by Campus Bio-Medico University at 2 sites in Italy.
Trial summary
Patients who developed an acute coronary syndrome despite dual antiplatelet therapy with aspirin and clopidogrel may benefit from a further dose of clopidogrel before a percutaneous coronary intervention. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Acute Coronary Syndrome, Myocardial Infarction
- What is being tested?
- Clopidogrel
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 240 participants
- Where
- 2 sitesItaly
- Study dates
- Nov 2011to May 2012
- 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- chronic (> 10 days) therapy with clopidogrel (75 mg/day)
- non-ST-segment elevation acute coronary syndrome (ACS) requiring early diagnostic angiography
Who cannot join
- primary percutaneous coronary intervention (PCI) for acute ST-segment elevation acute myocardial infarction
- platelet count < 70 × 10^9/L
- high bleeding risk
- coronary bypass grafting in the previous 3 months
Trial locations and contacts
2 sites in 1 country.
Italy2 sites, 2 recruiting
- Recruiting
Vito Fazzi Hospital
Lecce, Lecce, 73100
Giuseppe Colonna, MD
Antonio Montinaro, MD
- Recruiting
Campus Bio-Medico University
Rome, Rome, 00128
Giuseppe Patti, MD
Vincenzo Vizzi, MD
About this study
Official title: Clopidogrel Reloading in Patients With Non-ST Elevation Acute Coronary Syndrome Undergoing PCI on Chronic Clopidogrel Therapy. Results of the ARMYDA RELOAD ACS (Antiplatelet Therapy for Reduction of MYocardial Damage During Angioplasty in Acute Coronary Syndrome) Randomized Trial.
Patients who developed an acute coronary syndrome despite dual antiplatelet therapy with aspirin and clopidogrel may benefit from a further dose of clopidogrel before a percutaneous coronary intervention.
The aim of this study is to evaluate safety and effectiveness of clopidogrel reloading in patients on chronic clopidogrel therapy with acute coronary syndrome undergoing percutaneous coronary intervention.
- Conditions
- Acute Coronary Syndrome, Myocardial Infarction
- Being tested
- Clopidogrel, Placebo
- Medical subject headings
- Acute Coronary Syndrome, Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ClopidogrelDrug
Also called Plavix
600 mg clopidogrel loading dose 6-8 h before diagnostic coronary angiogram
PlaceboDrug
Placebo in addition to the chronic daily dose of 75 mg
| Study group | Role | What they receive |
|---|---|---|
| Reload | Experimental | 600 mg of clopidogrel loading dose 6-8 h before coronary angiogram, in addition to the chronic daily dose of 75 mg Receives: Drug: Clopidogrel |
| Placebo | Placebo comparator | Placebo arm in addition to the chronic daily dose of 75 mg Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Major Adverse Cardiovascular Events
Death Myocardial Infarction Target Vessel Revascularization
Measured: 30 days
Secondary outcomes (2)
Bleeding Events
Occurrence of vascular/bleeding complications, defined as: (a) major bleeding (intracranial bleeding or clinically overt bleeding associated with a decrease in haemoglobin >5 g/dL, according to the TIMI criteria); (b) minor bleeding (clinically overt haemorrhage associated with a fall in haemoglobin ≤5 g/dL); (c) entry-site complications (haematoma >5 cm, pseudoaneurysm or arteriovenous fistula)
Measured: 30 days
Grade of platelet residual reactivity
Patient's response to clopidogrel at 3 different timing, assessed with VerifyNow P2Y12 Assays.
The first timing is immediately before PCI (4-6h after randomization), once accomplished the diagnostic angiogram.
The second and third timings are, respectively, 8h and 24h after PCI.
Measured: Immediately before PCI (4-6h after randomization), 8h and 24h after PCI
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2012 (estimated)
- Study startNov 2011
- Primary completionMay 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Campus Bio-Medico University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Patti Giuseppe, Campus Bio-Medico University
- Investigators
- Giuseppe Patti, MD, Principal investigator, Campus Bio-Medico University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01572129
- Sponsor's protocol ID
- 2011-005449-11
- Status last verified
- Apr 2012
- First submitted
- 3 Apr 2012
- Last updated
- 6 Apr 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Di Sciascio G, Patti G, Pasceri V, Colonna G, Mangiacapra F, Montinaro A; ARMYDA-4 RELOAD Investigators. Clopidogrel reloading in patients undergoing percutaneous coronary intervention on chronic clopidogrel therapy: results of the ARMYDA-4 RELOAD (Antiplatelet therapy for Reduction of MYocardial Damage during Angioplasty) randomized trial. Eur Heart J. 2010 Jun;31(11):1337-43. doi: 10.1093/eurheartj/ehq081. Epub 2010 Apr 2.
PubMed 20363764Kastrati A, von Beckerath N, Joost A, Pogatsa-Murray G, Gorchakova O, Schomig A. Loading with 600 mg clopidogrel in patients with coronary artery disease with and without chronic clopidogrel therapy. Circulation. 2004 Oct 5;110(14):1916-9. doi: 10.1161/01.CIR.0000137972.74120.12. Epub 2004 Jul 19.
PubMed 15262828
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clopidogrel Reloading in Patients With Non-ST Elevation Acute Coronary Syndrome Undergoing PCI on Chronic Clopidogrel Therapy. Results of the ARMYDA RELOAD ACS (Antiplatelet Therapy for Reduction of MYocardial Damage During Angioplasty in Acute Coronary Syndrome) Randomized Trial.
- ClinicalTrials.gov ID
- NCT01572129
- Acronym / sponsor ID
- 2011-005449-11
- Conditions
- Acute Coronary Syndrome, Myocardial Infarction
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Campus Bio-Medico UniversityUniversity, hospital or other
- Study start
- Nov 2011
- Primary completion
- May 2012 (estimated)
- First posted
- 6 Apr 2012 (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.
Patients who developed an acute coronary syndrome despite dual antiplatelet therapy with aspirin and clopidogrel may benefit from a further dose of clopidogrel before a percutaneous coronary intervention.
The aim of this study is to evaluate safety and effectiveness of clopidogrel reloading in patients on chronic clopidogrel therapy with acute coronary syndrome undergoing percutaneous coronary intervention.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Reload | Experimental | Drug: Clopidogrel600 mg of clopidogrel loading dose 6-8 h before coronary angiogram, in addition to the chronic daily dose of 75 mg |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo arm in addition to the chronic daily dose of 75 mg |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- chronic (> 10 days) therapy with clopidogrel (75 mg/day)
- non-ST-segment elevation acute coronary syndrome (ACS) requiring early diagnostic angiography
Key exclusion criteria (4 listed)
- primary percutaneous coronary intervention (PCI) for acute ST-segment elevation acute myocardial infarction
- platelet count < 70 × 10^9/L
- high bleeding risk
- coronary bypass grafting in the previous 3 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 |
|---|---|---|
| ClopidogrelAlso: Plavix600 mg clopidogrel loading dose 6-8 h before diagnostic coronary angiogram | Drug | Reload |
| PlaceboPlacebo in addition to the chronic daily dose of 75 mg | Drug | Placebo |
Primary outcome
Major Adverse Cardiovascular Events
Time frame: 30 days
Death Myocardial Infarction Target Vessel Revascularization
2 secondary outcomes
Bleeding Events
Time frame: 30 days
Grade of platelet residual reactivity
Time frame: Immediately before PCI (4-6h after randomization), 8h and 24h after PCI
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2012.
- Background: PubMed 20363764Di Sciascio G, Patti G, Pasceri V, Colonna G, Mangiacapra F, Montinaro A; ARMYDA-4 RELOAD Investigators. Clopidogrel reloading in patients undergoing percutaneous coronary intervention on chronic clopidogrel therapy: results of the ARMYDA-4 RELOAD (Antiplatelet therapy for Reduction of MYocardial Damage during Angioplasty) randomized trial. Eur Heart J. 2010 Jun;31(11):1337-43. doi: 10.1093/eurheartj/ehq081. Epub 2010 Apr 2.
- Background: PubMed 15262828Kastrati A, von Beckerath N, Joost A, Pogatsa-Murray G, Gorchakova O, Schomig A. Loading with 600 mg clopidogrel in patients with coronary artery disease with and without chronic clopidogrel therapy. Circulation. 2004 Oct 5;110(14):1916-9. doi: 10.1161/01.CIR.0000137972.74120.12. Epub 2004 Jul 19.
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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.
Giuseppe Patti, MD principal investigator
Campus Bio-Medico University
2 sites 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 in people with Acute Coronary Syndrome and Myocardial Infarction, run by Campus Bio-Medico University at 2 sites 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 2 inclusion and 4 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 6 Apr 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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. Some participants in this study may receive a placebo. 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?
Contact Giuseppe Patti, MD (06225411899, g.patti@unicampus.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Major Adverse Cardiovascular Events (time frame: 30 days). 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 NCT01572129, which also lists 2 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 6 Apr 2012.