Platelet DysfunctionPhase 2STATIPLATNCT01526460
Evaluation of Platelet Function After Statin Loading Dose in Patients Before Percutaneous Coronary Intervention
A Phase 2 study testing Atorvastatin and Rosuvastatin in people with Platelet Dysfunction, run by IRCCS San Raffaele at 1 site in Italy.
Trial summary
The purpose of this study is to evaluate the effect of a loading dose of two different statins on platelet reactivity (atorvastatin, metabolized by CYP3A4, and rosuvastatin, which is rather independent of this enzyme)in patients at least 5 days in therapy with aspirin and clopidogrel (with or without an undergoing… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Platelet Dysfunction
- What is being tested?
- Atorvastatin and Rosuvastatin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 146 participants
- Where
- 1 siteItaly
- Study dates
- Aug 2011to Feb 2014
- Phase
- Phase 2
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age: 18-75 years
- Patients with chronic stable angina
- Patients with coronary artery disease or with de novo stent restenosis of native vessels.
- Patients who are able to understand the significance of this study and to adhere to recruitment by signing the informed consent.
Who cannot join
- Acute Coronary Syndromes with an enzymatic movement (STEMI, NSTEMI).
- Allergy or intolerance to atorvastatin, rosuvastatin, aspirin, clopidogrel.
- Altered basal level of transaminase or CPK.
- Patient with history of hepatitis-acute/chronic.
- Patients already receiving high-dose statins.
- Contraindications to antiplatelet therapy.
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- Patients with acute inflammatory disease and/or underlying chronic (hepatitis, pneumonia, urinary tract, rectum ulcerative colitis etc.).
- Patients with anemia (haemoglobin <8.5 mg/dl), leukocytosis (WBC> 12.000 mm3), leukopenia (WBC <3000 mm3), platelet count <100.000; hypersplenism.
- Patients with malignant disease.
- Patients enrolled in other studies not yet completed.
- Patients with known allergy / intolerance to statins.
- Pregnant women and women who are breastfeeding.
- Patients with myopathy (muscle pain and unexplained repeated)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective, Randomized, Single Center, Open Label Study Designed to Evaluate the Effect on Platelet Reactivity in Response to High Doses of Atorvastatin or Rosuvastatin Administered Before Percutaneous Coronary Intervention (PCI)
The purpose of this study is to evaluate the effect of a loading dose of two different statins on platelet reactivity (atorvastatin, metabolized by CYP3A4, and rosuvastatin, which is rather independent of this enzyme)in patients at least 5 days in therapy with aspirin and clopidogrel (with or without an undergoing treatment with statins) undergoing PCI for coronary disease with chronic stable angina and/or evidence of inducible myocardial ischemia.
Read the detailed description
An initial assessment of platelet reactivity in response to the TRAP (thrombin receptor agonist), ADP and arachidonic acid (respectively, indicative of the response to clopidogrel and aspirin) will be performed with impedance aggregometry (Multiplate® analyzer system). Patients with a increased residual platelet reactivity to ADP test (AUC > 47) will receive a different antiplatelet therapy and will then be excluded from the study, the other will be randomized to 3 groups of treatment.
- Conditions
- Platelet Dysfunction
- Being tested
- Atorvastatin, Rosuvastatin, Placebo
- Keywords
- Platelet, Atorvastatin, Rosuvastatin, Multiplate, reactivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AtorvastatinDrug
Also called TORVAST, TOTALIP
80 mg
RosuvastatinDrug
Also called CRESTOR
40 mg
PlaceboDrug
Also called NO STATIN DRUGS
no statin loading dose
| Study group | Role | What they receive |
|---|---|---|
| Atorvastatin | Active comparator | Atorvastatin 80 mg Receives: Drug: Atorvastatin |
| Rosuvastatin | Active comparator | Rosuvastatin 40 mg Receives: Drug: Rosuvastatin |
| No statin loading dose | Placebo comparator | No statin loading dose Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area Under the Aggregation Curve (AUC) measured with the Multiplate 5.0 Analyzer
Evaluation of the effect of a loading dose (LD) of two different statins on platelet reactivity (atorvastatin and rosuvastatin) in terms of difference between AUC value before statin LD and after 12 hrs statin LD. The Area Under the Aggregation Curve (AUC) will be measured with the Multiplate 5.0 system.
Measured: Evaluation of platelet reactivity (in terms of AUC) two time points.
Secondary outcomes (1)
Incidence of periprocedural myocardial infarction
To evaluate if the loading dose of statin prevent the periprocedural myocardial damage measured by CK and CK-MB The measurments will be done once before the procedure and at 6 and 12 hours after.
Measured: CK and CK-MB evaluated before the procedure and two time points up to 12 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2012 (estimated)
- Study startAug 2011
- Primary completionFeb 2014
- Study completionFeb 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Platelet DysfunctionStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 146 participants (actual)
Sponsor and investigators
- Lead sponsor
- IRCCS San Raffaele
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Antonio Colombo, IRCCS San Raffaele
- Investigators
- Antonio Colombo, MD, Principal investigator, IRCCS San Raffaele Monte Tabor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01526460
- Sponsor's protocol ID
- STATIPLAT
- Acronym
- STATIPLAT
- Status last verified
- Mar 2014
- First submitted
- 14 Sep 2011
- Last updated
- 6 Mar 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Randomized, Single Center, Open Label Study Designed to Evaluate the Effect on Platelet Reactivity in Response to High Doses of Atorvastatin or Rosuvastatin Administered Before Percutaneous Coronary Intervention (PCI)
- ClinicalTrials.gov ID
- NCT01526460
- Acronym / sponsor ID
- STATIPLAT / STATIPLAT
- Conditions
- Platelet Dysfunction
- Keywords
- Platelet, Atorvastatin, Rosuvastatin, Multiplate, reactivity
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 146 participants (actual)
- Lead sponsor
- IRCCS San RaffaeleUniversity, hospital or other
- Study start
- Aug 2011
- Primary completion
- Feb 2014 (actual)
- Study completion
- Feb 2014 (actual)
- First posted
- 3 Feb 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.
The purpose of this study is to evaluate the effect of a loading dose of two different statins on platelet reactivity (atorvastatin, metabolized by CYP3A4, and rosuvastatin, which is rather independent of this enzyme)in patients at least 5 days in therapy with aspirin and clopidogrel (with or without an undergoing treatment with statins) undergoing PCI for coronary disease with chronic stable angina and/or evidence of inducible myocardial ischemia.
Detailed description
An initial assessment of platelet reactivity in response to the TRAP (thrombin receptor agonist), ADP and arachidonic acid (respectively, indicative of the response to clopidogrel and aspirin) will be performed with impedance aggregometry (Multiplate® analyzer system). Patients with a increased residual platelet reactivity to ADP test (AUC > 47) will receive a different antiplatelet therapy and will then be excluded from the study, the other will be randomized to 3 groups of treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Atorvastatin | Active comparator | Drug: AtorvastatinAtorvastatin 80 mg |
| Rosuvastatin | Active comparator | Drug: RosuvastatinRosuvastatin 40 mg |
| No statin loading dose | Placebo comparator | Drug: PlaceboNo statin loading dose |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age: 18-75 years
- Patients with chronic stable angina
- Patients with coronary artery disease or with de novo stent restenosis of native vessels.
- Patients who are able to understand the significance of this study and to adhere to recruitment by signing the informed consent.
Key exclusion criteria (13 listed)
- Acute Coronary Syndromes with an enzymatic movement (STEMI, NSTEMI).
- Allergy or intolerance to atorvastatin, rosuvastatin, aspirin, clopidogrel.
- Altered basal level of transaminase or CPK.
- Patient with history of hepatitis-acute/chronic.
- Patients already receiving high-dose statins.
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 |
|---|---|---|
| AtorvastatinAlso: TORVAST, TOTALIP80 mg | Drug | Atorvastatin |
| RosuvastatinAlso: CRESTOR40 mg | Drug | Rosuvastatin |
| PlaceboAlso: NO STATIN DRUGSno statin loading dose | Drug | No statin loading dose |
Primary outcome
Area Under the Aggregation Curve (AUC) measured with the Multiplate 5.0 Analyzer
Time frame: Evaluation of platelet reactivity (in terms of AUC) two time points.
Evaluation of the effect of a loading dose (LD) of two different statins on platelet reactivity (atorvastatin and rosuvastatin) in terms of difference between AUC value before statin LD and after 12 hrs statin LD. The Area Under the Aggregation Curve (AUC) will be measured with the Multiplate 5.0 system.
1 secondary outcome
Incidence of periprocedural myocardial infarction
Time frame: CK and CK-MB evaluated before the procedure and two time points up to 12 hours
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 6 Mar 2014.
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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.
Antonio Colombo, MD principal investigator
IRCCS San Raffaele Monte Tabor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Atorvastatin and Rosuvastatin in people with Platelet Dysfunction, run by IRCCS San Raffaele 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 4 inclusion and 13 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 6 Mar 2014. 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. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Area Under the Aggregation Curve (AUC) measured with the Multiplate 5.0 Analyzer (time frame: Evaluation of platelet reactivity (in terms of AUC) two time points.). 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 6 Mar 2014.