Coronary Artery DiseasePhase 4NCT01260584
The Influence of Smoking Status on Prasugrel and Clopidogrel Treated Subjects Taking Aspirin and Having Stable Coronary Artery Disease
A Phase 4 study testing Prasugrel and Clopidogrel in people with Coronary Artery Disease, run by Daiichi Sankyo at 3 sites in United States.
Trial summary
This study is being conducted to determine if smoking will influence the platelet aggregation inhibition ability of clopidogrel and prasugrel. It will also determine if smoking has any effect on the plasma concentrations of the active metabolite of prasugrel and the active and inactive metabolites of clopidogrel. Read more about this study
- Who is it for?
- Ages 18 to 74 years
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- Prasugrel and Clopidogrel
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 3 sitesUnited States
- Study dates
- Nov 2010to Sep 2011
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 74 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female subjects > or = 18 years and <75 years of age;
- Weight > or = 60 kg;
- On aspirin therapy (81 mg to 325 mg daily) at the time of screening and able to maintain a consistent aspirin dosing regimen from the baseline visit through the final study visit;
- Subjects who do not have contraindications for a thienopyridine (ie, prasugrel, clopidogrel, or ticlopidine) and have a history of stable atherosclerosis represented by CAD, defined as any of the following:
- Chronic stable angina;
- Documented prior ACS event > or = 30 days before screening and not currently prescribed or currently on thienopyridine therapy;
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- Previous coronary revascularization including percutaneous transluminal coronary angioplasty, stent, or coronary artery bypass graft;
- Coronary Artery Disease (> or = 40% obstruction) in at least one coronary vessel after angiography;
- Documented history of positive stress test; or
- High coronary artery calcium score (> or = 90th percentile for age and gender) determined by cardiac computed tomography scan;
- Current smokers who smoke > or = ½ pack per day of cigarettes with a NicAlert™ level of 6;
- Non-smokers with a NicAlert level of 0, 1, or 2;
- Female subjects who meet one of the following:
- Women of childbearing potential with a negative serum pregnancy test at screening, who are not breastfeeding, do not plan to become pregnant during the study, and agree to use an approved method of birth control during the study. Approved methods of birth control are intrauterine device, diaphragm plus spermicide, or female condom plus spermicide. Abstinence, partner's use of condoms, partner's vasectomy, and hormonal contraceptives are NOT acceptable methods of contraception;
- Women who have been postmenopausal for at least 1 year or have had a hysterectomy, bilateral salpingo-oophorectomy, or tubal ligation at least 6 months prior to signing the Informed Consent Form (ICF); and
- Subjects with a competent mental condition to provide written informed consent before entering the study.
Who cannot join
- Subjects who received a bare metal stent and/or a drug-eluting stent within the last 12 months;
- Subjects who have had an angiogram < or = 7 days before randomization;
- Any other formal indication for the use of a thienopyridine;
- Subjects with a history of refractory ventricular arrhythmias;
- Subjects with a history of an implantable defibrillator device;
- Subjects with a history or evidence of congestive heart failure (New York Heart Association Class III or above) within 6 months prior to screening;
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- Subjects with significant hypertension (systolic blood pressure >180 mmHg or diastolic blood pressure >110 mmHg) at either the time of screening or baseline assessment;
- Bleeding risk exclusion criteria:
- Any known contraindication to treatment with an anticoagulant or antiplatelet agent;
- Prior history or clinical suspicion of cerebral vascular malformations, intracranial tumor, transient ischemic attack, or stroke, or recent history (within 3 months) of head trauma;
- Prior history or presence of significant bleeding disorders (eg, hematemesis, melena, severe or recurrent epistaxis, hemoptysis, hematuria, or intraocular bleeding);
- History (within the last 5 years) or presence of gastric ulcers. Previous history of duodenal ulcer is acceptable but must have been successfully surgically or medically treated with no further evidence of disease in the past 6 months (from screening);
- Prior history of abnormal bleeding tendency (ie, prolonged bleeding on dental extraction, tonsillectomy, or previous surgical procedure);
- Known prior history or presence of thrombocytopenia (platelet count <100,000/mm3) or thrombocytosis (platelet count >500,000/mm3) or recent history (within 6 months) of hemoglobin <10 mg/dL;
- International normalized ratio (INR) >1.5 or activated partial thromboplastin time (aPTT) > upper limit of normal (ULN) of laboratory reference range at screening;
- History of major surgery, severe trauma, fracture, or organ biopsy within 3 months prior to enrollment;
- Prior/concomitant therapy exclusion criteria:
- Subjects taking prasugrel, clopidogrel, ticlopidine, cilostazol, dipyridamole, warfarin, heparin, direct thrombin inhibitors, or GPIIb/IIIa inhibitors < or = 10 days prior to randomization or during study participation;
- Use (or planned use) of fibrinolytic agents within 30 days before screening or during study participation;
- Subjects receiving treatment with nonsteroidal anti-inflammatory drugs or cyclooxygenase-2 inhibitors exceeding 3 doses per week;
- Subjects taking proton pump inhibitors (eg, lansoprazole, esomeprazole, omeprazole, pantoprazole, or rabeprazole) < or = 10 days prior to randomization or during study participation;
- Use or planned use of any herbal supplements < or = 10 days prior to randomization or during study participation;
- Use or planned use of the following strong inhibitors of various CYP pathways < or =10 days prior to randomization or during study participation: ciprofloxacin, cimetidine, fluvoxamine, estradiol, ethinylestradiol, fluconazole, amiodarone, indinavir, nelfinavir, ritonavir, saquinavir, clarithromycin, erythromycin, telithromycin, itraconazole, ketoconazole, fluconazole, nefazodone, or grapefruit-containing products;
- Use or planned use of the following strong inducers of various CYP pathways < or = 10 days prior to randomization or during study participation: rifampin, barbiturates, carbamazepine, dexamethasone, or St. John's Wort;
- Female subjects taking hormonal contraception or hormonal replacement therapy during study participation;
- General exclusion criteria:
- Investigative site personnel directly affiliated with the study or immediate family of investigative site personnel directly affiliated with the study. Immediate family is defined as a spouse, parent, child, or sibling, whether biological or legally adopted;
- Daiichi Sankyo or Eli Lilly employees;
- Currently enrolled in, or discontinued within the last 30 days from, any clinical study involving an investigational drug or device;
- Have previously completed or withdrawn from this study;
- Women who are known to be pregnant and/or who receive a positive serum pregnancy test result, and/or who have given birth within the past 90 days, and/or who are breastfeeding;
- Results of clinical laboratory tests at the time of screening that are judged to be clinically significant for the subject, as determined by the Investigator;
- Known allergies or intolerance to aspirin and/or thienopyridines (prasugrel, clopidogrel, or ticlopidine);
- Evidence of significant active neuropsychiatric disease, alcohol abuse, or drug abuse, in the Investigator's opinion;
- Evidence of active hepatic disease or any of the following: positive human immunodeficiency virus antibodies; positive hepatitis C antibody; positive hepatitis B surface antigen; serum alanine transaminase, aspartate transaminase, or gamma-glutamyltransferase > or = 3 × ULN of laboratory reference range; or bilirubin > or = 2 × ULN of laboratory reference range at screening;
- Subjects who are unwilling to make themselves available for the duration of the study and who will not abide by the research unit policy and procedure and study restrictions.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Sanai Center for Thrombosis Research
Baltimore, Maryland, 21215
Medpace Clinical Pharmacology Unit
Cincinnati, Ohio, 45212
The Carl and Edyth Lindner Center for Research and Education at the Christ Hospital
Cincinnati, Ohio, 45219
About this study
Official title: The Influence of Smoking Status on the Pharmacokinetics and Pharmacodynamics of Prasugrel and Clopidogrel in Aspirin-treated Subjects With Stable Coronary Artery Disease
This study is being conducted to determine if smoking will influence the platelet aggregation inhibition ability of clopidogrel and prasugrel. It will also determine if smoking has any effect on the plasma concentrations of the active metabolite of prasugrel and the active and inactive metabolites of clopidogrel.
The primary hypothesis is that smoking status will influence the antiplatelet effects and active metabolite concentrations of clopidogrel but will have no impact on prasugrel's antiplatelet effects or active metabolite concentrations.
Read the detailed description
Subjects will be stratified according to smoking status prior to being randomized to 1 of the 2 treatment sequences: prasugrel 10 mg daily for 10 days followed by clopidogrel 75 mg daily for 10 days or clopidogrel 75 mg daily for 10 days followed by prasugrel 10 mg daily for 10 days. There will be a 14-day Washout Period between Active Treatment Period 1 (when subjects receive the first drug of the sequence) and the second Active Treatment Period 2 (Period 3) (when subjects receive the second drug of the sequence). All subjects will remain on the same dose of aspirin from baseline throughout the study.
- Conditions
- Coronary Artery Disease
- Being tested
- Prasugrel, Clopidogrel
- Keywords
- thienopyridine, antiplatelet, prasugrel, clopidogrel
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PrasugrelDrug
Also called Effient
One 10 mg film-coated, oral tablet daily x 10 days. In addition, aspirin 81 mg to 325 mg daily will be taken.
ClopidogrelDrug
Also called Plavix
One 75 mg film-coated, oral tablet daily x 10 days. In addition, aspirin 81 mg to 325 mg daily will be taken.
| Study group | Role | What they receive |
|---|---|---|
| Prasugrel | Experimental | Prasugrel 10 mg film-coated tablet daily dose × 10 days. To maintain blinding, placebo film-coated tablets matching clopidogrel in appearance will be given daily × 10 days to subjects in the prasugrel treatment group. In addition, aspirin 81 mg to 325 mg daily will be taken. Receives: Drug: Prasugrel |
| Clopidogrel | Active comparator | Clopidogrel 75 mg film-coated tablet daily dose x 10 days To maintain blinding, placebo film-coated tablets matching prasugrel in appearance will be given daily × 10 days to subjects in the clopidogrel treatment group. In addition, aspirin 81 mg to 325 mg daily will be taken. Receives: Drug: Clopidogrel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Inhibition of Platelet Aggregation (IPA) in Prasugrel-treated and Clopidogrel-treated Smokers and Non-smokers Following 9 Days of Maintenance Therapy.
IPA will be measured by the Accumetrics P2Y12 Assay Device. Response will be assessed in P2Y12 Reaction Units and as Platelet Reactivity Index (vasodilator-stimulated phosphoprotein assay).
Measured: Baseline to day 10 for Active Treatment Periods 1 and 2
Secondary outcomes (6)
Assessment of P2Y12 Reaction Units (PRU) by Treatment and Smoking Status
Day 10 occurs in each treatment period at which time data collections are made. 12.1.4. Responders and Poor Responders
Numerous studies have established an association between high on-treatment platelet reactivity with clopidogrel and an increased risk for post-PCI ischemic events. In this study, the percentages of "responders" and "poor responders" following treatment with prasugrel and clopidogrel were compared. Poor responders were defined based on an Accumetrics VerifyNow PRU >235 and a VASP PRI >50%, as assessed 24 hours after the 9th maintenance dose.
Measured: Day 10 for Active Treatment Periods 1 and 2
Assessment of Vasodilator Stimulated Phosphoprotein (VASP) by Treatment and Smoking Status
Day 10 occurs in each treatment period at which time data collections are made. Numerous studies have established an association between high on-treatment platelet reactivity with clopidogrel and an increased risk for post-PCI ischemic events. In this study, the percentages of "responders" and "poor responders" following treatment with prasugrel and clopidogrel were compared. Poor responders were defined based on an Accumetrics VerifyNow PRU >235 and a VASP PRI >50%, as assessed 24 hours after the 9th maintenance dose.
Measured: Day 10 for Active Treatment Periods 1 and 2
Responder Rate by Treatment and Smoking Status Based on P2Y12 Reaction Units (PRU) <= 235
Measured: Day 10 for Active Treatment Periods 1 and 2
Responder Rate by Treatment and Smoking Status Based on Platelet Reactivity Index (PRI) <= 50%
Numerous studies have established an association between high on-treatment platelet reactivity with clopidogrel and an increased risk for post-PCI ischemic events. In this study, the percentages of "responders" and "poor responders" following treatment with prasugrel and clopidogrel were compared. Poor responders were defined based on an Accumetrics VerifyNow PRU >235 and a VASP PRI >50%, as assessed 24 hours after the 9th maintenance dose.
Measured: Day 10 for Active Treatment Periods 1 and 2
Characterization of the Pharmacokinetics (PK) Area Under Curve (AUC)(0-Last) of the Active Metabolite of Prasugrel and the Active Metabolite of Clopidogrel in Smokers and Non-smokers
Blood samples for determination of plasma concentrations of the prasugrel active metabolite, clopidogrel active metabolite, and clopidogrel inactive metabolite will be collected following the administration of the 10th (last) maintenance dose of each of the 2 Active Treatment Periods at 0.5, 1, 2, 4, and 6 hours post-dose.
Measured: After dose on Day 10 of Active Treatment Periods 1 and 2
Characterization of the Pharmacokinetics (PK) Cmax of the Active Metabolite of Prasugrel and the Active Metabolite of Clopidogrel in Smokers and Non-smokers
Measured: After dose on Day 10 of Active Treatment Periods 1 and 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2010 (estimated)
- Study startNov 2010
- Primary completionSep 2011
- Study completionSep 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- More trials run by Daiichi SankyoThe sponsor's other registered studies.
- 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
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Daiichi Sankyo
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Paul Gurbel, MD, Principal investigator, Sinai Center for Thrombosis Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01260584
- Sponsor's protocol ID
- CS747S-B-U4002
- Status last verified
- Nov 2012
- First submitted
- 13 Dec 2010
- Last updated
- 9 Jan 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Yes: De-identified individual participant data (IPD) and applicable supporting clinical trial documents may be available upon request at https://vivli.org/. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://vivli.org/ourmember/daiichi-sankyo/
Publications
Gurbel PA, Bliden KP, Logan DK, Kereiakes DJ, Lasseter KC, White A, Angiolillo DJ, Nolin TD, Maa JF, Bailey WL, Jakubowski JA, Ojeh CK, Jeong YH, Tantry US, Baker BA. The influence of smoking status on the pharmacokinetics and pharmacodynamics of clopidogrel and prasugrel: the PARADOX study. J Am Coll Cardiol. 2013 Aug 6;62(6):505-12. doi: 10.1016/j.jacc.2013.03.037. Epub 2013 Apr 16.
PubMed 23602770
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influence of Smoking Status on the Pharmacokinetics and Pharmacodynamics of Prasugrel and Clopidogrel in Aspirin-treated Subjects With Stable Coronary Artery Disease
- ClinicalTrials.gov ID
- NCT01260584
- Acronym / sponsor ID
- CS747S-B-U4002
- Conditions
- Coronary Artery Disease
- Keywords
- thienopyridine, antiplatelet, prasugrel, clopidogrel
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Daiichi SankyoIndustry (pharma, biotech, devices)
- Study start
- Nov 2010
- Primary completion
- Sep 2011 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 15 Dec 2010 (estimated)
- Results
- Posted 12 Dec 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is being conducted to determine if smoking will influence the platelet aggregation inhibition ability of clopidogrel and prasugrel. It will also determine if smoking has any effect on the plasma concentrations of the active metabolite of prasugrel and the active and inactive metabolites of clopidogrel.
The primary hypothesis is that smoking status will influence the antiplatelet effects and active metabolite concentrations of clopidogrel but will have no impact on prasugrel's antiplatelet effects or active metabolite concentrations.
Detailed description
Subjects will be stratified according to smoking status prior to being randomized to 1 of the 2 treatment sequences: prasugrel 10 mg daily for 10 days followed by clopidogrel 75 mg daily for 10 days or clopidogrel 75 mg daily for 10 days followed by prasugrel 10 mg daily for 10 days. There will be a 14-day Washout Period between Active Treatment Period 1 (when subjects receive the first drug of the sequence) and the second Active Treatment Period 2 (Period 3) (when subjects receive the second drug of the sequence). All subjects will remain on the same dose of aspirin from baseline throughout the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prasugrel | Experimental | Drug: PrasugrelPrasugrel 10 mg film-coated tablet daily dose × 10 days. To maintain blinding, placebo film-coated tablets matching clopidogrel in appearance will be given daily × 10 days to subjects in the prasugrel treatment group. In addition, aspirin 81 mg to 325 mg daily will be taken. |
| Clopidogrel | Active comparator | Drug: ClopidogrelClopidogrel 75 mg film-coated tablet daily dose x 10 days To maintain blinding, placebo film-coated tablets matching prasugrel in appearance will be given daily × 10 days to subjects in the clopidogrel treatment group. In addition, aspirin 81 mg to 325 mg daily will be taken. |
Who may qualify
- Ages
- 18 to 74 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Male or female subjects > or = 18 years and <75 years of age;
- Weight > or = 60 kg;
- On aspirin therapy (81 mg to 325 mg daily) at the time of screening and able to maintain a consistent aspirin dosing regimen from the baseline visit through the final study visit;
- Subjects who do not have contraindications for a thienopyridine (ie, prasugrel, clopidogrel, or ticlopidine) and have a history of stable atherosclerosis represented by CAD, defined as any of the following:
- Current smokers who smoke > or = ½ pack per day of cigarettes with a NicAlert™ level of 6;
Key exclusion criteria (36 listed)
- Subjects who received a bare metal stent and/or a drug-eluting stent within the last 12 months;
- Subjects who have had an angiogram < or = 7 days before randomization;
- Any other formal indication for the use of a thienopyridine;
- Subjects with a history of refractory ventricular arrhythmias;
- Subjects with a history of an implantable defibrillator device;
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 |
|---|---|---|
| PrasugrelAlso: EffientOne 10 mg film-coated, oral tablet daily x 10 days. In addition, aspirin 81 mg to 325 mg daily will be taken. | Drug | Prasugrel |
| ClopidogrelAlso: PlavixOne 75 mg film-coated, oral tablet daily x 10 days. In addition, aspirin 81 mg to 325 mg daily will be taken. | Drug | Clopidogrel |
Primary outcome
Inhibition of Platelet Aggregation (IPA) in Prasugrel-treated and Clopidogrel-treated Smokers and Non-smokers Following 9 Days of Maintenance Therapy.
Time frame: Baseline to day 10 for Active Treatment Periods 1 and 2
IPA will be measured by the Accumetrics P2Y12 Assay Device. Response will be assessed in P2Y12 Reaction Units and as Platelet Reactivity Index (vasodilator-stimulated phosphoprotein assay).
6 secondary outcomes
Assessment of P2Y12 Reaction Units (PRU) by Treatment and Smoking Status
Time frame: Day 10 for Active Treatment Periods 1 and 2
Assessment of Vasodilator Stimulated Phosphoprotein (VASP) by Treatment and Smoking Status
Time frame: Day 10 for Active Treatment Periods 1 and 2
Responder Rate by Treatment and Smoking Status Based on P2Y12 Reaction Units (PRU) <= 235
Time frame: Day 10 for Active Treatment Periods 1 and 2
Responder Rate by Treatment and Smoking Status Based on Platelet Reactivity Index (PRI) <= 50%
Time frame: Day 10 for Active Treatment Periods 1 and 2
Characterization of the Pharmacokinetics (PK) Area Under Curve (AUC)(0-Last) of the Active Metabolite of Prasugrel and the Active Metabolite of Clopidogrel in Smokers and Non-smokers
Time frame: After dose on Day 10 of Active Treatment Periods 1 and 2
Characterization of the Pharmacokinetics (PK) Cmax of the Active Metabolite of Prasugrel and the Active Metabolite of Clopidogrel in Smokers and Non-smokers
Time frame: After dose on Day 10 of Active Treatment Periods 1 and 2
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 23602770Gurbel PA, Bliden KP, Logan DK, Kereiakes DJ, Lasseter KC, White A, Angiolillo DJ, Nolin TD, Maa JF, Bailey WL, Jakubowski JA, Ojeh CK, Jeong YH, Tantry US, Baker BA. The influence of smoking status on the pharmacokinetics and pharmacodynamics of clopidogrel and prasugrel: the PARADOX study. J Am Coll Cardiol. 2013 Aug 6;62(6):505-12. doi: 10.1016/j.jacc.2013.03.037. Epub 2013 Apr 16.
- Individual participant dataSharing planned: Yes. De-identified individual participant data (IPD) and applicable supporting clinical trial documents may be available upon request at https://vivli.org/. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://vivli.org/ourmember/daiichi-sankyo/
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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.
Paul Gurbel, MD principal investigator
Sinai Center for Thrombosis Research
3 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 Prasugrel and Clopidogrel in people with Coronary Artery Disease, run by Daiichi Sankyo at 3 sites in United States.
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 16 inclusion and 36 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 9 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. 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?
Yes. Results are posted in the registry (first posted 12 Dec 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Inhibition of Platelet Aggregation (IPA) in Prasugrel-treated and Clopidogrel-treated Smokers and Non-smokers Following 9 Days of Maintenance Therapy. (time frame: Baseline to day 10 for Active Treatment Periods 1 and 2). 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 NCT01260584, 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 9 Jan 2019; AzTrials last refreshed its copy on 8 Nov 2026.