Acute Coronary SyndromePhase 4SWITCH 600/60NCT01365221
The Effect of Reloading Prasugrel in a Patient Who Has Already Received a Loading Dose (LD) of Clopidogrel
A Phase 4 study testing Prasugrel in people with Acute Coronary Syndrome, run by Medstar Health Research Institute at 4 sites in United States.
Trial summary
The primary objective of this study is to compare platelet reactivity between patients receiving a loading dose of clopidogrel and a reloading dose of prasugrel to patients receiving only a loading dose of prasugrel. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Acute Coronary Syndrome
- What is being tested?
- Prasugrel
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 77 participants
- Where
- 4 sitesUnited States
- Study dates
- Oct 2010to Jan 2014
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients age 18 or older, of both genders
- Presenting with an ACS, defined as at least two of the following:
- Symptoms consistent with myocardial ischemia; ST segment elevation or depression of at least 1 mm in 2 or more contiguous leads on EKG; Cardiac troponin I level above the upper limit of normal.
- An initial invasive strategy (e.g. early angiography) is planned.
- No contraindications to prasugrel therapy.
Who cannot join
- Known allergies to aspirin, clopidogrel, or prasugrel.
- Patient known to be pregnant or lactating.
- Patient with known history of bleeding diathesis, or currently active bleeding.
- Platelet count <100,000/mm3 at the time of enrollment.
- Hematocrit <25% at the time of enrollment.
- On warfarin therapy at the time of PCI, or patient likely to require warfarin therapy post-PCI.
Show all 18Show fewer
- Received fibrinolytics within the past 48 hours.
- Received a glycoprotein IIb/IIIa inhibitor within the past 48 hours, or if a strategy for PCI involving a glycoprotein IIb/IIIa inhibitor is planned.
- Taking maintenance thienopyridine therapy in the previous 7 days.
- Known blood transfusion within the preceding 10 days.
- Patients treated with non-steroidal anti-inflammatory drugs (NSAIDS) within the previous 5 days.
- Patients with known chronic liver disease.
- Age greater than 75 years.
- Body weight less than 60 kg.
- History of stroke or transient ischemic attack.
- Surgery planned within 1 month.
- Patient likely to require coronary artery bypass grafting.
- Any significant medical condition that, in the investigator's opinion, may interfere with the patient's optimal participation in the study.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Sinai Center for Thrombosis Research
Baltimore, Maryland, 21215
The Heart Center
Huntsville, Alabama, 35801
Saint Luke's Hospital
Kansas City, Missouri, 64111
Washington Hospital Center
Washington D.C., District of Columbia, 20010
About this study
Official title: SWITCH 600/60: The Effect of Reloading Prasugrel in a Patient Who Has Already Received a Loading Dose (LD) of Clopidogrel
The primary objective of this study is to compare platelet reactivity between patients receiving a loading dose of clopidogrel and a reloading dose of prasugrel to patients receiving only a loading dose of prasugrel.
Read the detailed description
This is a prospective, open-label, non-randomized trial of approximately 260 patients with Acute Coronary Syndrome (ACS) undergoing percutaneous coronary intervention (PCI). In order to compare platelet reactivity, as assessed by the VerifyNow P2Y12 assay, we plan to recruit two study groups of interest:
- Patients who have already received a 600 mg loading dose (LD) of clopidogrel in preparation for PCI will receive a loading dose of 60 mg of prasugrel.
- Patients who have not received a LD of clopidogrel will receive a 60 mg LD of prasugrel prior to PCI.
A subset of 40 patients from each study group (80 patients total) will undergo additional platelet reactivity testing with the vasodilator stimulated phosphoprotein (VASP) assay.All patients will be followed throughout the duration of the hospital stay.
- Conditions
- Acute Coronary Syndrome
- Being tested
- Prasugrel
- Keywords
- Acute Coronary Syndrome, Clopidogrel, Prasugrel
- Medical subject headings
- Acute Coronary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PrasugrelDrug
Patients who have received 600 mg loading dose of clopidogrel will receive a reloading dose of 60 mg prasugrel
PrasugrelDrug
Patients who have not received a loading dose of clopidogrel will receive a 60 mg loading dose of prasugrel.
| Study group | Role | What they receive |
|---|---|---|
| Patients who have received loading dose of clopidogrel | Experimental | Not described Receives: Drug: Prasugrel |
| Patients who have not received loading dose of clopidogrel | Active comparator | Not described Receives: Drug: Prasugrel |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary objective is to compare platelet reactivity, as assessed by the VerifyNow P2Y12 assay, between patients receiving a loading dose of clopidogrel and a reloading dose of prasugrel to patients receiving only a loading dose of prasugrel.
Measured: Average hospital stay is 24-48 hours.
Secondary outcomes (1)
The secondary objective of this study is to describe rates of bleeding events associated with a loading dose of prasugrel in patients who have already received a loading dose of clopidogrel.
Measured: Average hospital stay is 24-48 hours.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2011 (estimated)
- Study startOct 2010
- Primary completionJan 2014
- Study completionJan 2014
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 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 77 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medstar Health Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ron Waksman, MD, Principal investigator, Medstar Health Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01365221
- Sponsor's protocol ID
- SWITCH 600/60
- Acronym
- SWITCH 600/60
- Status last verified
- Sep 2020
- First submitted
- 11 May 2011
- Last updated
- 9 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
Publications
Lhermusier T, Lipinski MJ, Drenning D, Marso S, Chen F, Torguson R, Waksman R. Switching patients from clopidogrel to prasugrel in acute coronary syndrome: impact of the clopidogrel loading dose on platelet reactivity. J Interv Cardiol. 2014 Aug;27(4):365-72. doi: 10.1111/joic.12139. Epub 2014 Jul 19.
PubMed 25041356
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SWITCH 600/60: The Effect of Reloading Prasugrel in a Patient Who Has Already Received a Loading Dose (LD) of Clopidogrel
- ClinicalTrials.gov ID
- NCT01365221
- Acronym / sponsor ID
- SWITCH 600/60 / SWITCH 600/60
- Conditions
- Acute Coronary Syndrome
- Keywords
- Acute Coronary Syndrome, Clopidogrel, Prasugrel
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 77 participants (actual)
- Lead sponsor
- Medstar Health Research InstituteUniversity, hospital or other
- Study start
- Oct 2010 (actual)
- Primary completion
- Jan 2014 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 3 Jun 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 primary objective of this study is to compare platelet reactivity between patients receiving a loading dose of clopidogrel and a reloading dose of prasugrel to patients receiving only a loading dose of prasugrel.
Detailed description
This is a prospective, open-label, non-randomized trial of approximately 260 patients with Acute Coronary Syndrome (ACS) undergoing percutaneous coronary intervention (PCI). In order to compare platelet reactivity, as assessed by the VerifyNow P2Y12 assay, we plan to recruit two study groups of interest:
- Patients who have already received a 600 mg loading dose (LD) of clopidogrel in preparation for PCI will receive a loading dose of 60 mg of prasugrel.
- Patients who have not received a LD of clopidogrel will receive a 60 mg LD of prasugrel prior to PCI.
A subset of 40 patients from each study group (80 patients total) will undergo additional platelet reactivity testing with the vasodilator stimulated phosphoprotein (VASP) assay.All patients will be followed throughout the duration of the hospital stay.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients who have received loading dose of clopidogrel | Experimental | Drug: Prasugrel |
| Patients who have not received loading dose of clopidogrel | Active comparator | Drug: Prasugrel |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients age 18 or older, of both genders
- Presenting with an ACS, defined as at least two of the following:
- Symptoms consistent with myocardial ischemia; ST segment elevation or depression of at least 1 mm in 2 or more contiguous leads on EKG; Cardiac troponin I level above the upper limit of normal.
- An initial invasive strategy (e.g. early angiography) is planned.
- No contraindications to prasugrel therapy.
Key exclusion criteria (18 listed)
- Known allergies to aspirin, clopidogrel, or prasugrel.
- Patient known to be pregnant or lactating.
- Patient with known history of bleeding diathesis, or currently active bleeding.
- Platelet count <100,000/mm3 at the time of enrollment.
- Hematocrit <25% at the time of enrollment.
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 |
|---|---|---|
| PrasugrelPatients who have received 600 mg loading dose of clopidogrel will receive a reloading dose of 60 mg prasugrel | Drug | Patients who have received loading dose of clopidogrel |
| PrasugrelPatients who have not received a loading dose of clopidogrel will receive a 60 mg loading dose of prasugrel. | Drug | Patients who have not received loading dose of clopidogrel |
Primary outcome
The primary objective is to compare platelet reactivity, as assessed by the VerifyNow P2Y12 assay, between patients receiving a loading dose of clopidogrel and a reloading dose of prasugrel to patients receiving only a loading dose of prasugrel.
Time frame: Average hospital stay is 24-48 hours.
1 secondary outcome
The secondary objective of this study is to describe rates of bleeding events associated with a loading dose of prasugrel in patients who have already received a loading dose of clopidogrel.
Time frame: Average hospital stay is 24-48 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 9 Sep 2020.
- Results publication: PubMed 25041356Lhermusier T, Lipinski MJ, Drenning D, Marso S, Chen F, Torguson R, Waksman R. Switching patients from clopidogrel to prasugrel in acute coronary syndrome: impact of the clopidogrel loading dose on platelet reactivity. J Interv Cardiol. 2014 Aug;27(4):365-72. doi: 10.1111/joic.12139. Epub 2014 Jul 19.
Related trials for Acute Coronary Syndrome
Recruiting
CT Stress Myocardial Perfusion, Fractional Flow Reserve and Angiography in Patients With Stable Chest Pain Syndromes
Coronary Artery Disease, Chest Syndrome
Recruiting
WIN Ratio Analysis to Determine a Strategy of Non- Invasive SUpport for Respiratory Failure in the EmeRgency Department
Acute Hypoxic Respiratory Failure, Acute Respiratory Distress Syndrome (ARDS)
RecruitingPhase 4
Early Single Antiplatelet Therapy After IVUS-Guided PCI in Acute Coronary Syndrome
Acute Coronary Syndromes, STEMI
Recruiting
AI-Assisted Interpretation of Cardiac CT in the Emergency Department
Chest Pain, Acute Coronary Syndrome
Enrolling by invitation
Optical Coherence Tomography in Acute Vessel Evaluation
Ischemic Heart Disease, Ischemic Coronary Artery Disease
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.
Ron Waksman, MD principal investigator
Medstar Health Research Institute
4 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 in people with Acute Coronary Syndrome, run by Medstar Health Research Institute at 4 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 5 inclusion and 18 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 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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?
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?
The primary objective is to compare platelet reactivity, as assessed by the VerifyNow P2Y12 assay, between patients receiving a loading dose of clopidogrel and a reloading dose of prasugrel to patients receiving only a loading dose of prasugrel. (time frame: Average hospital stay is 24-48 hours.). 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 NCT01365221, 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 Sep 2020.