WARNING:
TICLID can cause life-threatening hematological adverse reactions, including neutropenia/agranulocytosis, thrombotic thrombocytopenic purpura (TTP) and aplastic anemia.
Neutropenia/Agranulocytosis:
Among 2048 patients in clinical trials in stroke patients, there were 50 cases (2.4%) of neutropenia (less than 1200 neutrophils/mm3), and the neutrophil count was below 450/mm3 in 17 of these patients (0.8% of the total population).
TTP:
One case of thrombotic thrombocytopenic purpura was reported during clinical trials in stroke patients. Based on postmarketing data, US physicians reported about 100 cases between 1992 and 1997. Based on an estimated patient exposure of 2 million to 4 million, and assuming an event reporting rate of 10% (the true rate is not known), the incidence of ticlopidine-associated TTP may be as high as one case in every 2000 to 4000 patients exposed.
Aplastic Anemia:
Aplastic anemia was not seen during clinical trials in stroke patients, but US physicians reported about 50 cases between 1992 and 1998. Based on an estimated patient exposure of 2 million to 4 million, and assuming an event reporting rate of 10% (the true rate is not known), the incidence of ticlopidine-associated aplastic anemia may be as high as one case in every 4000 to 8000 patients exposed.
Monitoring of Clinical and Hematologic Status:
Severe hematological adverse reactions may occur within a few days of the start of therapy. The incidence of TTP peaks after about 3 to 4 weeks of therapy and neutropenia peaks at approximately 4 to 6 weeks. The incidence of aplastic anemia peaks after about 4 to 8 weeks of therapy. The incidence of the hematologic adverse reactions declines thereafter. Only a few cases of neutropenia, TTP, or aplastic anemia have arisen after more than 3 months of therapy.
Hematological adverse reactions cannot be reliably predicted by any identified demographic or clinical characteristics. During the first 3 months of treatment, patients receiving TICLID must, therefore, be hematologically and clinically monitored for evidence of neutropenia or TTP. If any such evidence is seen, TICLID should be immediately discontinued.
The detection and treatment of ticlopidine-associated hematological adverse reactions are further described under WARNINGS.
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NEWS HIGHLIGHTS
Published Studies Related to Ticlid (Ticlopidine)
The safety and efficacy of clopidogrel versus ticlopidine in Japanese stroke patients: combined results of two Phase III, multicenter, randomized clinical trials. [2009.06]
Two Phase III studies comparing the safety and efficacy of clopidogrel with ticlopidine as antiplatelet agents for the secondary prevention of vascular events in patients with prior stroke were performed in Japan. Both studies were randomized, double-blind, double-dummy comparative trials with the primary objective of comparing the clinical safety of treatment with either clopidogrel or ticlopidine for up to 12 months...
Quantitative determination of ticlopidine hydrochloride in human plasma by high-performance liquid chromatography-electronspray ionization mass spectrometry. [2009]
A sensitive, selective and simple high performance liquid chromatographyelectrospray ionization-mass spectrometry (HPLC-ESI-MS) was developed and validated for the quantification of ticlopidine hydrochloride (CAS 53885-35-1) in human plasma using loratadine (CAS 79794-75-5) as internal standard (IS)...
Comparison of sarpogrelate and ticlopidine in bare metal coronary stent implantation. [2008.05.07]
BACKGROUND: The efficacy and safety of sarpogrelate, a selective 5-hydroxytryptamine receptor subtype 2A antagonist, have not yet been established in bare metal coronary stenting. Accordingly, we sought to clarify whether treatment with sarpogrelate is clinically useful in bare metal coronary stenting... CONCLUSIONS: The incidence of adverse drug reactions requiring a withdrawal of treatment was significantly lower with sarpogrelate use than with ticlopidine use. The rate of binary restenosis and the incidence of subacute stent thrombosis did not differ between both drug groups.
Bioequivalence of two preparations of ticlopidine evaluated using a pharmacodynamic end point. [2005.09]
CONCLUSIONS: The test and the reference products are bioequivalent on the basis of the ex vivo platelet aggregation test. Our study has shown that the bioequivalence of two different preparations can be assessed by measuring a pharmacodynamic end point in a suitably selected group of subjects.
A randomized trial comparing clopidogrel versus ticlopidine therapy in patients undergoing infarct artery stenting for acute myocardial infarction with abciximab as adjunctive therapy. [2005.08]
AIM: To evaluate the impact of a clopidogrel therapy on the effectiveness of myocardial reperfusion in patients with ST-segment elevation acute myocardial infarction (AMI) undergoing routine infarct-related artery (IRA) stent implantation and receiving routine abciximab therapy. BACKGROUND: Inflammatory processes after mechanical restoration of flow in AMI play a central role in decreasing the effectiveness of reperfusion at microcirculatory level. Several studies suggest that clopidogrel may exert a protective effect against adverse cardiovascular events by virtue of its anti-inflammatory properties... CONCLUSION: Clopidogrel has no impact on the effectiveness of myocardial reperfusion in patients with AMI treated routinely with stenting and abciximab. However, clopidogrel, administered as a 600-mg loading dose followed by 75 mg daily, is safe and at least as effective as the standard ticlopidine therapy in this subgroup of patients.
Clinical Trials Related to Ticlid (Ticlopidine)
Safety Evaluation of Clopidogrel Sulfate in Patients With Peripheral Arterial Disease [Recruiting]
Primary objective:
- To evaluate whether 12 weeks of clopidogrel is superior to ticlopidine in terms of
lower risk of the safety events of interests in patients with peripheral arterial
disease (PAD)
Secondary objectives:
- To compare the risk of bleeding adverse events, serious adverse events and overall
safety of clopidogrel with ticlopidine
- To compare the risk of vascular events of clopidogrel with ticlopidine
- To document the long-term safety of clopidogrel for a total of 52 weeks
- To document the vascular events of clopidogrel for a total of 52 weeks
Safety Evaluation of Clopidogrel Sulfate in Patients With Stable Angina/Old Myocardial Infarction to Whom Percutaneous Coronary Intervention is Being Planned [Recruiting]
Primary objective:
- To evaluate whether 12 weeks of clopidogrel is superior to ticlopidine in terms of
lower risk of the safety events of interest in patients with stable angina (SA) or old
myocardial infarction (OMI) to which percutaneous coronary intervention (PCI) is being
planned.
Secondary objectives:
- To compare the incidence of adverse events, adverse drug reactions and bleeding events
in patients treated with clopidogrel versus ticlopidine.
- To compare the incidence of major adverse cardiac events (MACE) and major adverse
cardiac and cerebrovascular events (MACCE) in patients treated with clopidogrel versus
ticlopidine
- To evaluate the long-term safety (adverse drug reactions, adverse events, safety events
of interest and bleeding events) of clopidogrel for a total of 52 weeks
- To evaluate MACE and MACCE of clopidogrel for a total of 52 weeks
Antiplatelet Therapy to Prevent Stroke in African Americans [Completed]
Efficacy and Safety in Patients With Acute Coronary Syndrome Without ST-Segment Elevation [Completed]
To evaluate the efficasy and safety of SR25990C(loading dose: 300mg, maintenance
dose: 75mg/day) in comparison with the standard Japanese treatment(ticlopidine) in patients
with acute coronary syndrome without ST-segment elevation and planned for percutaneous
coronary intervention(including stenting).
Trial to Assess the Safety and Effects of SCH 530348 in Japanese Subjects With Acute Coronary Syndrome (P04772)(COMPLETED) [Completed]
The study is designed to assess safety and effects of SCH 530348, when added to standard of
care (aspirin and clopidigrel), in Japanese subjects with acute coronary syndrome. The study
may also provide information about the effect of SCH 530348 on preventing heart attack and
stroke in this subject population.
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