Angioplasty, Transluminal, Percutaneous CoronaryPhase 43T/2RNCT00398463
Study of Tirofiban Administration in Patients With Aspirin and or Clopidogrel Resistance
A Phase 4 study testing Tirofiban in people with Angioplasty, Transluminal, Percutaneous Coronary, run by Università degli Studi di Ferrara at 1 site in Italy.
Trial summary
This study will evaluate whether adding tirofiban, administered at high bolus dose on top of aspirin and clopidogrel will lead to a lower rate of periprocedural myocardial infarction after percutaneous coronary intervention in elective patients presenting with aspirin and/or clopidogrel resistance. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Angioplasty, Transluminal, Percutaneous Coronary
- What is being tested?
- Tirofiban
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 263 participants
- Where
- 1 siteItaly
- Study dates
- May 2006to May 2011
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All Patients older than 18 years scheduled for coronary angiography and/or PCI will be enrolled. [Patients should be CK-MB negative (to avoid CK washout with revascularization) and also cTnI/T negative whereas other high-risk features will not lead to patient exclusion.
- All consecutive patients with stable or unstable troponin and CK-MB negative coronary artery disease showing aspirin and or clopidogrel resistance (ACR) will be enrolled. These include:
- Patients with clinical indication to undergo angiography for possible revascularisation.
- Patients with ACR in whom catheter-based coronary intervention is planned based on previous angiogram.
Who cannot join
- Patients who can not give informed consent or have a life expectancy of < 1 year
- Evolving or Ongoing myocardial infarction (MI) (Persistence of or developing Q wave or ST segment elevation at ECG with or without typical chest pain or typical rapid rise and fall CK-MB or new LBBB) or patients in whom the treating physician intends to use a Gp IIB/IIIa inhibitors.
- Administration of any GP IIb/IIIa receptor antagonist, anticoagulation, or lytic therapy in the previous 30 days
- Serum creatinine more than 2.5 mg/dl (221 micromol/L)
- Ongoing bleeding or bleeding diathesis or contraindication for anticoagulation or increase bleeding risk or history of bleeding in the last 1 year
- Previous stroke or TIA or any intracranial pathology in the last six months
Show all 11Show fewer
- Major surgery or trauma within the previous six weeks
- Platelet count < 100.000 per cubic mm or HCT ,33% or Hb < 11 gm/dL
- Subjects who received low-molecular-weight heparin within the 24 hours prior to randomization
- Subjects with an allergy or intolerance to aspirin, heparin, clopidogrel, or tirofiban
- Patients with severe hypertension (SBP > 180 mm Hg or DBP > 110 mm Hg) or in cardiogenic shock (SBP 80 mm Hg or below for > 30 minutes) or requiring IABP
Trial locations and contacts
1 site in 1 country.
Italy1 site
Cattedra di Cardiologia, Azienda Ospedaliera Universitaria di Ferrara
Ferrara, Fe, 44100
About this study
Official title: Tailoring Treatment With Tirofiban in Patients Showing Resistance to Aspirin and/or Resistance to Clopidogrel
This study will evaluate whether adding tirofiban, administered at high bolus dose on top of aspirin and clopidogrel will lead to a lower rate of periprocedural myocardial infarction after percutaneous coronary intervention in elective patients presenting with aspirin and/or clopidogrel resistance.
Read the detailed description
This study will investigate the effect of treatment with a high bolus dosage of Tirofiban (in addition to Aspirin, Heparin and 300mg or 600mg clopidogrel) on the rate of periprocedural myocardial infarction compared to Aspirin, Heparin (or bivalirudin) and 300mg or 600mg clopidogrel alone in patients resistant to aspirin and/or to clopidogrel.
This is a randomized, double blind, placebo controlled (with bailout tirofiban as rescue) multicenter study. Enrollment will last between 12 and 36 months depending on the final number of participating centres. The minimum follow-up will be 30 days after the index procedure.
- Being tested
- Tirofiban, Placebo
- Keywords
- tirofiban, aspirin resistance, clopidogrel resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TirofibanDrug
Also called Glycoprotein IIb/IIIa inhibitor
Tirofiban infusion given as high bolus dose plus standard 14-24 hour infusion
PlaceboDrug
Also called Glycoprotein IIb/IIIa inhibitor
Saline infusion will be administered for 14-24 hours
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Aspirin, clopidogrel, Unfractioned heparin or bivalirudin plus tirofiban infusion given at high bolus dose Receives: Drug: Tirofiban |
| 2 | Placebo comparator | Aspirin, clopidogrel, Unfractioned heparin or bivalirudin plus placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Troponin I or T elevation ratio at least three times the upper limit of normal.
Measured: 48 hours
Secondary outcomes (5)
The incidence of myocardial infarction defined as elevation of CK-MB >1, ≥3 or ≥5 times the ULN in one or more blood sample(s).
Measured: 30 days
Elevation of troponin levels above upper limit of normal in ratios different from the primary endpoint
Measured: within 30 days
Bleeding rates
Measured: 30 days
Stent thrombosis
Measured: with the first year of follow-up
The rate of major adverse cardiovascular events
Measured: at 30 days and 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2006 (estimated)
- Study startMay 2006
- Primary completionJul 2008
- Study completionMay 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Angioplasty, Transluminal, Percutaneous CoronaryStudies 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 263 participants (actual)
Sponsor and investigators
- Lead sponsor
- Università degli Studi di Ferrara
- Sponsor type
- University, hospital or other
- Investigators
- Marco Valgimigli, MD, PhD, Principal investigator, Università degli Studi di Ferrara
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00398463
- Sponsor's protocol ID
- TCA-01-III
- Acronym
- 3T/2R
- Status last verified
- Jun 2008
- First submitted
- 9 Nov 2006
- Last updated
- 1 Jul 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Chen WH, Lee PY, Ng W, Tse HF, Lau CP. Aspirin resistance is associated with a high incidence of myonecrosis after non-urgent percutaneous coronary intervention despite clopidogrel pretreatment. J Am Coll Cardiol. 2004 Mar 17;43(6):1122-6. doi: 10.1016/j.jacc.2003.12.034.
PubMed 15028378Valgimigli M, Percoco G, Barbieri D, Ferrari F, Guardigli G, Parrinello G, Soukhomovskaia O, Ferrari R. The additive value of tirofiban administered with the high-dose bolus in the prevention of ischemic complications during high-risk coronary angioplasty: the ADVANCE Trial. J Am Coll Cardiol. 2004 Jul 7;44(1):14-9. doi: 10.1016/j.jacc.2004.03.042.
PubMed 15234398Valgimigli M, Campo G, de Cesare N, Meliga E, Vranckx P, Furgieri A, Angiolillo DJ, Sabate M, Hamon M, Repetto A, Colangelo S, Brugaletta S, Parrinello G, Percoco G, Ferrari R; Tailoring Treatment With Tirofiban in Patients Showing Resistance to Aspirin and/or Resistance to Clopidogrel (3T/2R) Investigators. Intensifying platelet inhibition with tirofiban in poor responders to aspirin, clopidogrel, or both agents undergoing elective coronary intervention: results from the double-blind, prospective, randomized Tailoring Treatment with Tirofiban in Patients Showing Resistance to Aspirin and/or Resistance to Clopidogrel study. Circulation. 2009 Jun 30;119(25):3215-22. doi: 10.1161/CIRCULATIONAHA.108.833236. Epub 2009 Jun 15.
PubMed 19528337
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tailoring Treatment With Tirofiban in Patients Showing Resistance to Aspirin and/or Resistance to Clopidogrel
- ClinicalTrials.gov ID
- NCT00398463
- Acronym / sponsor ID
- 3T/2R / TCA-01-III
- Keywords
- tirofiban, aspirin resistance, clopidogrel resistance
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 263 participants (actual)
- Lead sponsor
- Università degli Studi di FerraraUniversity, hospital or other
- Study start
- May 2006
- Primary completion
- Jul 2008 (actual)
- Study completion
- May 2011 (actual)
- First posted
- 10 Nov 2006 (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.
This study will evaluate whether adding tirofiban, administered at high bolus dose on top of aspirin and clopidogrel will lead to a lower rate of periprocedural myocardial infarction after percutaneous coronary intervention in elective patients presenting with aspirin and/or clopidogrel resistance.
Detailed description
This study will investigate the effect of treatment with a high bolus dosage of Tirofiban (in addition to Aspirin, Heparin and 300mg or 600mg clopidogrel) on the rate of periprocedural myocardial infarction compared to Aspirin, Heparin (or bivalirudin) and 300mg or 600mg clopidogrel alone in patients resistant to aspirin and/or to clopidogrel.
This is a randomized, double blind, placebo controlled (with bailout tirofiban as rescue) multicenter study. Enrollment will last between 12 and 36 months depending on the final number of participating centres. The minimum follow-up will be 30 days after the index procedure.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: TirofibanAspirin, clopidogrel, Unfractioned heparin or bivalirudin plus tirofiban infusion given at high bolus dose |
| 2 | Placebo comparator | Drug: PlaceboAspirin, clopidogrel, Unfractioned heparin or bivalirudin plus placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- All Patients older than 18 years scheduled for coronary angiography and/or PCI will be enrolled. [Patients should be CK-MB negative (to avoid CK washout with revascularization) and also cTnI/T negative whereas other high-risk features will not lead to patient exclusion.
- All consecutive patients with stable or unstable troponin and CK-MB negative coronary artery disease showing aspirin and or clopidogrel resistance (ACR) will be enrolled. These include:
Key exclusion criteria (11 listed)
- Patients who can not give informed consent or have a life expectancy of < 1 year
- Evolving or Ongoing myocardial infarction (MI) (Persistence of or developing Q wave or ST segment elevation at ECG with or without typical chest pain or typical rapid rise and fall CK-MB or new LBBB) or patients in whom the treating physician intends to use a Gp IIB/IIIa inhibitors.
- Administration of any GP IIb/IIIa receptor antagonist, anticoagulation, or lytic therapy in the previous 30 days
- Serum creatinine more than 2.5 mg/dl (221 micromol/L)
- Ongoing bleeding or bleeding diathesis or contraindication for anticoagulation or increase bleeding risk or history of bleeding in the last 1 year
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 |
|---|---|---|
| TirofibanAlso: Glycoprotein IIb/IIIa inhibitorTirofiban infusion given as high bolus dose plus standard 14-24 hour infusion | Drug | 1 |
| PlaceboAlso: Glycoprotein IIb/IIIa inhibitorSaline infusion will be administered for 14-24 hours | Drug | 2 |
Primary outcome
Troponin I or T elevation ratio at least three times the upper limit of normal.
Time frame: 48 hours
5 secondary outcomes
The incidence of myocardial infarction defined as elevation of CK-MB >1, ≥3 or ≥5 times the ULN in one or more blood sample(s).
Time frame: 30 days
Elevation of troponin levels above upper limit of normal in ratios different from the primary endpoint
Time frame: within 30 days
Bleeding rates
Time frame: 30 days
Stent thrombosis
Time frame: with the first year of follow-up
The rate of major adverse cardiovascular events
Time frame: at 30 days and 1 year
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 1 Jul 2011.
- Background: PubMed 15028378Chen WH, Lee PY, Ng W, Tse HF, Lau CP. Aspirin resistance is associated with a high incidence of myonecrosis after non-urgent percutaneous coronary intervention despite clopidogrel pretreatment. J Am Coll Cardiol. 2004 Mar 17;43(6):1122-6. doi: 10.1016/j.jacc.2003.12.034.
- Background: PubMed 15234398Valgimigli M, Percoco G, Barbieri D, Ferrari F, Guardigli G, Parrinello G, Soukhomovskaia O, Ferrari R. The additive value of tirofiban administered with the high-dose bolus in the prevention of ischemic complications during high-risk coronary angioplasty: the ADVANCE Trial. J Am Coll Cardiol. 2004 Jul 7;44(1):14-9. doi: 10.1016/j.jacc.2004.03.042.
- Derived from this study: PubMed 19528337Valgimigli M, Campo G, de Cesare N, Meliga E, Vranckx P, Furgieri A, Angiolillo DJ, Sabate M, Hamon M, Repetto A, Colangelo S, Brugaletta S, Parrinello G, Percoco G, Ferrari R; Tailoring Treatment With Tirofiban in Patients Showing Resistance to Aspirin and/or Resistance to Clopidogrel (3T/2R) Investigators. Intensifying platelet inhibition with tirofiban in poor responders to aspirin, clopidogrel, or both agents undergoing elective coronary intervention: results from the double-blind, prospective, randomized Tailoring Treatment with Tirofiban in Patients Showing Resistance to Aspirin and/or Resistance to Clopidogrel study. Circulation. 2009 Jun 30;119(25):3215-22. doi: 10.1161/CIRCULATIONAHA.108.833236. Epub 2009 Jun 15.
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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.
Marco Valgimigli, MD, PhD principal investigator
Università degli Studi di Ferrara
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 Tirofiban in people with Angioplasty, Transluminal, Percutaneous Coronary, run by Università degli Studi di Ferrara 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 11 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 1 Jul 2011. 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 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?
Troponin I or T elevation ratio at least three times the upper limit of normal. (time frame: 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 NCT00398463, which also lists 3 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 1 Jul 2011.