Stable AnginaPhase 4ACHIDONCT01335048
Atorvastatin and Clopidogrel HIgh DOse in Stable Patients With Residual High Platelet Activity
A Phase 4 study testing atorvastatin and clopidogrel and Clopidogrel in people with Stable Angina, run by Ospedale Misericordia e Dolce at 1 site in Italy.
Trial summary
The purpose of this study is to evaluate if high-dose (80mg/day) atorvastatin might exert an adjunctive anti-platelet effect compared to high-dose clopidogrel (150mg/day) in stable patients with high on-treatment reactivity according to a point-of-care platelet function assay. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Stable Angina
- What is being tested?
- atorvastatin and clopidogrel and Clopidogrel
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteItaly
- Study dates
- Apr 2011to Jan 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Stable angina
- candidates to drug eluting stent implantation
- High on-treatment platelet reactivity according to a point-of-care platelet function test
Who cannot join
- chronic therapy with statins
- inability to provide informed consent
- intolerance to statins
- acute or chronic liver failure or ALT > 2 times ULN
- known myopathy
- CKD stage IV or dialysis treatment
- pregnancy or breast-feeding
- malignancy
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to evaluate if high-dose (80mg/day) atorvastatin might exert an adjunctive anti-platelet effect compared to high-dose clopidogrel (150mg/day) in stable patients with high on-treatment reactivity according to a point-of-care platelet function assay.
Read the detailed description
This is a prospective, randomized, open-label, control-active trial performed in elective patients candidates to coronary drug eluting stent implantation who presented high-on-treatment platelet reactivity, immediately before coronary intervention (PCI). All patients are treated with aspirin (100 mg/day) and standard-dose clopidogrel (600 mg as loading dose and 75 mg daily as maintenance dose)for at least 7 days before PCI. Platelet function is assessed by the VerifyNow P2Y12 assay (Accumetrics, San Diego, CA). Patients are eligible to be enrolled if they have high-on-treatment reactivity defined as P2Y12 reaction units (PRU) >= 230, immediately before PCI. After PCI, patients are randomized to receive high-dose clopidogrel (150 mg daily) or high-dose atorvastatin (80mg/day) + high-dose clopidogrel (150 mg daily). Study visits and platelet function testing with the VerifyNow P2Y12 test are conducted at 7 and 30 days after randomization.
- Conditions
- Stable Angina
- Being tested
- atorvastatin and clopidogrel, Clopidogrel
- Keywords
- Clopidogrel, Statins, Platelet reactivity, Point-of-care platelet function test
- Medical subject headings
- Angina, Stable
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
atorvastatin and clopidogrelDrug
Atorvastatin 80 mg daily + clopidogrel 150 mg daily
ClopidogrelDrug
Clopidogrel 150 mg daily
| Study group | Role | What they receive |
|---|---|---|
| Atorvastatin-Clopidogrel group | Experimental | Patients who receive Atorvastatin 80 mg/day and Clopidogrel 150 mg/day Receives: Drug: atorvastatin and clopidogrel |
| Clopidogrel group | Active comparator | Patients who receive clopidogrel 150 mg daily Receives: Drug: Clopidogrel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in on-treatment platelet reactivity at 7 and 30 days
Pharmacodynamic analysis of the randomized groups includes a) assessment of the absolute level of on-treatment reactivity, b) change in on-treatment reactivity, c) rate of high on-treatment reactivity at 7 and 30 days. The platelet reactivity is measured with the VerifyNow P2Y12 test (Accumetrics, SanDiego, CA).
Measured: pre-PCI, 7 days and 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2011 (estimated)
- Study startApr 2011
- Primary completionDec 2011
- Study completionJan 2012
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 Stable AnginaStudies 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
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ospedale Misericordia e Dolce
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Toso Anna, Ospedale Misericordia e Dolce
- Investigators
- Mario Leoncini, MD, Principal investigator, Ospedale Misericordia e Dolce, PratoAnna Toso, MD, Principal investigator, Ospedale Misericordia e Dolce, Prato
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01335048
- Sponsor's protocol ID
- 6332011
- Acronym
- ACHIDO
- Status last verified
- Jan 2012
- First submitted
- 11 Apr 2011
- Last updated
- 26 Jan 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Leoncini M, Toso A, Maioli M, Angiolillo DJ, Giusti B, Marcucci R, Abbate R, Bellandi F. High-dose atorvastatin on the pharmacodynamic effects of double-dose clopidogrel in patients undergoing percutaneous coronary interventions: The ACHIDO (Atorvastatin and Clopidogrel HIgh DOse in stable patients with residual high platelet activity) study. JACC Cardiovasc Interv. 2013 Feb;6(2):169-79. doi: 10.1016/j.jcin.2012.09.013.
PubMed 23428009
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
- Atorvastatin and Clopidogrel HIgh DOse in Stable Patients With Residual High Platelet Activity
- ClinicalTrials.gov ID
- NCT01335048
- Acronym / sponsor ID
- ACHIDO / 6332011
- Conditions
- Stable Angina
- Keywords
- Clopidogrel, Statins, Platelet reactivity, Point-of-care platelet function test
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Ospedale Misericordia e DolceUniversity, hospital or other
- Study start
- Apr 2011
- Primary completion
- Dec 2011 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 13 Apr 2011 (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 purpose of this study is to evaluate if high-dose (80mg/day) atorvastatin might exert an adjunctive anti-platelet effect compared to high-dose clopidogrel (150mg/day) in stable patients with high on-treatment reactivity according to a point-of-care platelet function assay.
Detailed description
This is a prospective, randomized, open-label, control-active trial performed in elective patients candidates to coronary drug eluting stent implantation who presented high-on-treatment platelet reactivity, immediately before coronary intervention (PCI). All patients are treated with aspirin (100 mg/day) and standard-dose clopidogrel (600 mg as loading dose and 75 mg daily as maintenance dose)for at least 7 days before PCI. Platelet function is assessed by the VerifyNow P2Y12 assay (Accumetrics, San Diego, CA). Patients are eligible to be enrolled if they have high-on-treatment reactivity defined as P2Y12 reaction units (PRU) >= 230, immediately before PCI. After PCI, patients are randomized to receive high-dose clopidogrel (150 mg daily) or high-dose atorvastatin (80mg/day) + high-dose clopidogrel (150 mg daily). Study visits and platelet function testing with the VerifyNow P2Y12 test are conducted at 7 and 30 days after randomization.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Atorvastatin-Clopidogrel group | Experimental | Drug: atorvastatin and clopidogrelPatients who receive Atorvastatin 80 mg/day and Clopidogrel 150 mg/day |
| Clopidogrel group | Active comparator | Drug: ClopidogrelPatients who receive clopidogrel 150 mg daily |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Stable angina
- candidates to drug eluting stent implantation
- High on-treatment platelet reactivity according to a point-of-care platelet function test
Key exclusion criteria (8 listed)
- chronic therapy with statins
- inability to provide informed consent
- intolerance to statins
- acute or chronic liver failure or ALT > 2 times ULN
- known myopathy
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 |
|---|---|---|
| atorvastatin and clopidogrelAtorvastatin 80 mg daily + clopidogrel 150 mg daily | Drug | Atorvastatin-Clopidogrel group |
| ClopidogrelClopidogrel 150 mg daily | Drug | Clopidogrel group |
Primary outcome
Change from baseline in on-treatment platelet reactivity at 7 and 30 days
Time frame: pre-PCI, 7 days and 30 days
Pharmacodynamic analysis of the randomized groups includes a) assessment of the absolute level of on-treatment reactivity, b) change in on-treatment reactivity, c) rate of high on-treatment reactivity at 7 and 30 days. The platelet reactivity is measured with the VerifyNow P2Y12 test (Accumetrics, SanDiego, CA).
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.
- Derived from this study: PubMed 23428009Leoncini M, Toso A, Maioli M, Angiolillo DJ, Giusti B, Marcucci R, Abbate R, Bellandi F. High-dose atorvastatin on the pharmacodynamic effects of double-dose clopidogrel in patients undergoing percutaneous coronary interventions: The ACHIDO (Atorvastatin and Clopidogrel HIgh DOse in stable patients with residual high platelet activity) study. JACC Cardiovasc Interv. 2013 Feb;6(2):169-79. doi: 10.1016/j.jcin.2012.09.013.
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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.
Mario Leoncini, MD principal investigator
Ospedale Misericordia e Dolce, Prato
Anna Toso, MD principal investigator
Ospedale Misericordia e Dolce, Prato
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 atorvastatin and clopidogrel and Clopidogrel in people with Stable Angina, run by Ospedale Misericordia e Dolce 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 3 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: 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?
Change from baseline in on-treatment platelet reactivity at 7 and 30 days (time frame: pre-PCI, 7 days and 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 NCT01335048, 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 26 Jan 2012.